Bupivacaine Spinal Tung Grindeks: Uses, Dosage & Side Effects
A hyperbaric local anesthetic solution for intrathecal (spinal) anesthesia during surgical procedures of the lower body
Bupivacaine Spinal Tung Grindeks is a hyperbaric (heavy) solution of the local anesthetic bupivacaine, specifically formulated for intrathecal (spinal) administration. It contains bupivacaine hydrochloride 5 mg/ml with glucose 80 mg/ml, which makes the solution denser than cerebrospinal fluid. This property allows the anesthesiologist to control the spread and level of the spinal block by adjusting the patient’s position on the operating table. The medication is used exclusively in hospital settings to provide regional anesthesia for surgical procedures of the lower abdomen, pelvis, and lower extremities, including cesarean sections. Bupivacaine is included on the WHO Model List of Essential Medicines and remains one of the most widely used agents for spinal anesthesia worldwide.
Quick Facts: Bupivacaine Spinal Tung Grindeks
Key Takeaways
- Bupivacaine Spinal Tung Grindeks is a hyperbaric local anesthetic solution (5 mg/ml with 80 mg/ml glucose) designed exclusively for intrathecal injection to produce spinal anesthesia for lower body surgery.
- The hyperbaric formulation is denser than cerebrospinal fluid, allowing predictable control of the block level through patient positioning – a key advantage for anesthesiologists during surgery.
- Onset of action is rapid (1–5 minutes) and surgical anesthesia typically lasts 1.5–3.5 hours depending on dose, making it suitable for a wide range of surgical procedures.
- Must only be administered by or under the direct supervision of experienced anesthesiologists in facilities with full resuscitation equipment, as serious complications including high spinal block and cardiovascular toxicity can occur.
- Bupivacaine is on the WHO Model List of Essential Medicines and is one of the most extensively studied and widely used local anesthetics for spinal anesthesia globally.
What Is Bupivacaine Spinal Tung Grindeks and What Is It Used For?
Bupivacaine Spinal Tung Grindeks contains the active substance bupivacaine hydrochloride, an amide-type local anesthetic that has been in clinical use since the 1960s and remains one of the most important drugs in the field of regional anesthesia. Manufactured by AS Grindeks, a pharmaceutical company based in Latvia, this preparation is specifically formulated as a hyperbaric solution for intrathecal (spinal) administration. The term “hyperbaric” refers to the fact that the solution has a higher specific gravity (density) than the patient’s cerebrospinal fluid (CSF), achieved by the addition of glucose (dextrose) at a concentration of 80 mg/ml.
Spinal anesthesia, also known as subarachnoid block or intrathecal anesthesia, involves the injection of a small volume of local anesthetic solution directly into the subarachnoid space of the lumbar spine, where it mixes with the cerebrospinal fluid and acts on the spinal nerve roots. This produces a reversible loss of sensation (anesthesia), muscle relaxation (motor block), and blockade of the sympathetic nervous system in the regions supplied by the affected spinal segments. The result is a profound regional anesthesia of the lower body that allows surgical procedures to be performed without the patient experiencing pain, while the patient typically remains conscious or lightly sedated.
The hyperbaric nature of Bupivacaine Spinal Tung Grindeks is a crucial property that distinguishes it from isobaric (plain) bupivacaine formulations. Because the solution is denser than CSF, it tends to settle under the influence of gravity to the lowest point (the most dependent part) of the subarachnoid space. This means that the anesthesiologist can influence the spread and ultimate level of the spinal block by positioning the patient appropriately during and immediately after injection. For example, if the patient is placed in a seated position during injection and then lies flat, the hyperbaric solution will spread caudally (toward the sacrum), producing a lower and more restricted block. Conversely, tilting the operating table can encourage cephalad (upward) spread to achieve a higher block level. This predictability of spread is a significant clinical advantage and is one of the main reasons hyperbaric bupivacaine is the preferred agent for spinal anesthesia in many clinical scenarios.
Bupivacaine works by reversibly blocking voltage-gated sodium channels in the neuronal cell membranes of spinal nerve fibers. When injected intrathecally, it prevents the generation and conduction of electrical impulses (action potentials) along the nerve fibers responsible for transmitting sensory (pain, temperature, touch), motor (muscle contraction), and autonomic (sympathetic nervous system) signals. The order in which these nerve fibers are blocked depends on their diameter and degree of myelination: small unmyelinated sympathetic fibers are blocked first, followed by small myelinated sensory fibers (pain and temperature), and finally large myelinated motor fibers. This differential blockade is clinically useful because it means that sympathetic and sensory block typically extends to a higher spinal level than motor block.
Bupivacaine Spinal Tung Grindeks is indicated for the following surgical applications:
- Lower abdominal surgery: Including hernia repair (inguinal and femoral), appendectomy, and lower abdominal procedures where the required block level is typically T6–T10.
- Urological procedures: Transurethral resection of the prostate (TURP), transurethral resection of bladder tumors (TURBT), cystoscopy, and other urological operations.
- Orthopedic surgery of the lower extremities: Total hip replacement, total knee replacement, arthroscopy, fracture fixation, and foot and ankle procedures.
- Obstetric anesthesia: Cesarean section delivery, where spinal anesthesia is one of the most commonly used anesthetic techniques, as well as instrumental vaginal delivery.
- Perineal and perianal surgery: Hemorrhoidectomy, anal fistula repair, and other perianal procedures that require a saddle block (low spinal anesthesia restricted to the sacral dermatomes).
- Vascular surgery of the lower extremities: Peripheral vascular procedures, amputations, and varicose vein surgery.
The choice of spinal anesthesia over general anesthesia depends on many factors, including the type and duration of surgery, patient preference, coexisting medical conditions, and the expertise of the anesthesiologist. Spinal anesthesia with bupivacaine offers several well-documented advantages over general anesthesia for appropriate procedures: avoidance of airway manipulation, reduced risk of aspiration (particularly relevant in obstetric patients and those with full stomachs), better postoperative pain control in the immediate recovery period, lower incidence of postoperative nausea and vomiting, reduced blood loss in some surgical procedures (particularly orthopedic hip surgery), and earlier return of gastrointestinal function.
Bupivacaine is listed on the WHO Model List of Essential Medicines, recognizing it as one of the most important medications needed in a basic health system. Its inclusion reflects the drug’s well-established efficacy, favorable safety profile when used appropriately, long track record of clinical use, and importance in providing safe regional anesthesia in healthcare settings worldwide, including resource-limited environments.
What Should You Know Before Receiving Bupivacaine Spinal Tung Grindeks?
Before you receive spinal anesthesia with Bupivacaine Spinal Tung Grindeks, your anesthesiologist will conduct a thorough preoperative assessment. This evaluation includes a review of your medical history, current medications, previous anesthetic experiences (including any adverse reactions), allergies, and a focused physical examination. This assessment is critical to identify any contraindications to spinal anesthesia and to plan the most appropriate anesthetic technique for your individual situation.
Contraindications
Bupivacaine Spinal Tung Grindeks must not be used in the following circumstances:
- Known hypersensitivity: Allergy to bupivacaine, any other amide-type local anesthetic (such as lidocaine, ropivacaine, or mepivacaine), or any of the excipients in the formulation.
- Infection at the injection site: Active skin infection, abscess, or cellulitis at or near the planned lumbar puncture site, as this could introduce bacteria into the subarachnoid space, potentially leading to meningitis or spinal abscess.
- Severe hypovolemia or shock: Patients with uncorrected blood volume depletion are at significantly increased risk of severe hypotension following the sympathetic blockade produced by spinal anesthesia.
- Coagulation disorders: Clinically significant coagulopathies, thrombocytopenia (low platelet count), or concurrent therapeutic anticoagulation that has not been appropriately managed according to current guidelines (ASRA/ESRA), due to the risk of spinal epidural hematoma.
- Raised intracranial pressure: Elevated intracranial pressure, particularly when caused by a space-occupying lesion, as lumbar puncture in this setting may precipitate uncal herniation.
- Patient refusal: Patient refusal of the procedure is an absolute contraindication to any form of regional anesthesia. Informed consent is mandatory.
- Septicemia: Generalized sepsis (bloodstream infection) increases the risk of seeding infection into the neuraxis.
- Severe spinal deformities: Conditions that make lumbar puncture technically impossible or unpredictable, such as severe kyphoscoliosis or previous extensive spinal surgery with fusion, may preclude safe performance of spinal anesthesia.
Warnings and Precautions
Spinal anesthesia with bupivacaine must only be performed by or under the direct supervision of clinicians experienced in regional anesthesia techniques, in facilities equipped with resuscitation equipment, oxygen, and cardiovascular support medications. High or total spinal block with respiratory paralysis and cardiovascular collapse can occur and requires immediate intervention.
Several important warnings and precautions apply to the use of Bupivacaine Spinal Tung Grindeks:
- Cardiovascular monitoring: Continuous monitoring of heart rate, blood pressure, and oxygen saturation is mandatory throughout the procedure and for an appropriate period postoperatively. Hypotension is the most common hemodynamic effect of spinal anesthesia and occurs due to sympathetic nervous system blockade. Intravenous access must be established before the spinal injection, and vasopressor drugs (such as ephedrine or phenylephrine) should be immediately available.
- Elderly and debilitated patients: Older patients and those with reduced physiological reserve are more susceptible to the hemodynamic effects of spinal anesthesia. Lower doses of bupivacaine may be appropriate, and close cardiovascular monitoring is essential.
- Pre-existing cardiac disease: Patients with cardiac conditions such as heart block, decompensated heart failure, or severe valvular heart disease require careful consideration before spinal anesthesia, as the sympathetic blockade and resulting hemodynamic changes may be poorly tolerated.
- Hepatic impairment: Bupivacaine is metabolized primarily in the liver by cytochrome P450 CYP3A4. Patients with severe liver disease may have impaired metabolism of bupivacaine and are at increased risk of systemic toxicity. However, the doses used for spinal anesthesia are small, and clinically significant accumulation is unlikely with a single intrathecal injection.
- Spinal hematoma risk with anticoagulants: The use of neuraxial anesthesia in patients receiving anticoagulant or antiplatelet therapy requires careful timing according to established guidelines (ASRA/ESRA). Failure to observe appropriate time intervals between anticoagulant dosing and spinal needle insertion (or removal of an indwelling catheter) can result in spinal epidural hematoma, which is a rare but potentially devastating complication that can lead to permanent paralysis if not diagnosed and treated surgically within hours.
Pregnancy and Breastfeeding
Bupivacaine spinal anesthesia is one of the most commonly used anesthetic techniques for cesarean section and has a well-established safety record in obstetric practice. However, several pregnancy-related considerations apply:
Pregnant patients are more sensitive to local anesthetics due to hormonal and physiological changes of pregnancy. Progesterone increases neural sensitivity to local anesthetics, and the engorgement of epidural venous plexuses due to the gravid uterus compressing the inferior vena cava reduces the volume of the subarachnoid space, resulting in a wider spread of intrathecal local anesthetic. As a result, lower doses of bupivacaine are typically required in pregnant patients to achieve the desired block level. The standard dose for cesarean section is typically 10–12.5 mg of hyperbaric bupivacaine, often combined with an intrathecal opioid (such as fentanyl or morphine) to improve the quality of analgesia and allow a lower dose of local anesthetic.
Bupivacaine does cross the placenta, but when administered intrathecally at standard doses for spinal anesthesia, the amount reaching the fetus is very small and not considered clinically significant. Numerous large clinical studies and decades of clinical experience support the safety of spinal anesthesia with bupivacaine for both mother and baby during cesarean delivery. The primary risk to the fetus during spinal anesthesia for cesarean section is related to maternal hypotension, which can reduce uterine blood flow. This is managed with left uterine displacement (tilting the patient slightly to the left to relieve aortocaval compression), intravenous fluid administration, and vasopressor agents.
Regarding breastfeeding, bupivacaine administered intrathecally at standard doses results in very low systemic levels in the mother, and the amount excreted in breast milk is negligible. Breastfeeding can be safely initiated following spinal anesthesia with bupivacaine.
Driving and Operating Machinery
You must not drive or operate machinery until the effects of spinal anesthesia have completely resolved, including full return of sensation and motor function in the lower extremities. This typically takes several hours after the procedure, depending on the dose administered. Your healthcare team will advise you when it is safe to resume normal activities. Most patients are advised not to drive for at least 24 hours after any surgical procedure involving anesthesia.
How Does Bupivacaine Spinal Tung Grindeks Interact with Other Drugs?
While the doses of bupivacaine used in spinal anesthesia are small (typically 7.5–20 mg) and systemic absorption is limited, several important drug interactions must be considered. These interactions relate to the pharmacological effects of the spinal block itself, the potential for additive toxicity with other drugs, and the specific risks associated with neuraxial procedures in patients taking medications that affect blood coagulation.
| Drug / Drug Class | Interaction | Clinical Significance |
|---|---|---|
| Anticoagulants (warfarin, heparin, DOACs) | Increased risk of spinal epidural hematoma | High – strict timing guidelines must be followed |
| Antiplatelet agents (clopidogrel, aspirin, ticagrelor) | Increased bleeding risk at puncture site | High – may require discontinuation before procedure |
| Other local anesthetics | Additive systemic toxicity (CNS and cardiovascular) | Moderate – total dose of all local anesthetics must be considered |
| Antihypertensive medications | Enhanced hypotension from sympathetic blockade | Moderate – may require additional vasopressor support |
| Class III antiarrhythmics (amiodarone) | Additive cardiac depressant effects | Moderate – enhanced cardiac monitoring recommended |
| CYP3A4 inhibitors (ketoconazole, erythromycin) | Reduced hepatic metabolism of bupivacaine | Low – unlikely to be clinically relevant at intrathecal doses |
| Intrathecal opioids (fentanyl, morphine) | Synergistic analgesic effect; may enhance respiratory depression | Beneficial when monitored – commonly used combination |
Anticoagulants and Antiplatelet Agents (Critical Interaction)
The most clinically significant drug interaction relates to the risk of spinal epidural hematoma in patients receiving anticoagulant or antiplatelet medications. This is not a pharmacological interaction with bupivacaine itself, but rather a procedural risk associated with the spinal needle insertion. A spinal epidural hematoma is a collection of blood in or near the spinal canal that can compress the spinal cord, potentially causing permanent paraplegia if not diagnosed and surgically evacuated promptly. The risk is very low in patients with normal coagulation but is increased in patients receiving anticoagulants or antiplatelet drugs.
International guidelines from ASRA (American Society of Regional Anesthesia and Pain Medicine) and ESRA (European Society of Regional Anaesthesia and Pain Therapy) provide detailed recommendations on the timing of neuraxial procedures in relation to anticoagulant administration. Key recommendations include specific waiting periods before and after spinal needle insertion for each anticoagulant drug. For example, a minimum of 12 hours should elapse after a prophylactic dose of low-molecular-weight heparin (LMWH) before performing spinal anesthesia, and at least 4 hours should pass after the procedure before the next dose. For direct oral anticoagulants (DOACs), the recommended intervals are longer. Your anesthesiologist will assess your specific anticoagulant regimen and determine whether it is safe to proceed with spinal anesthesia.
Intrathecal Adjuvants (Beneficial Interactions)
In current clinical practice, intrathecal bupivacaine is frequently combined with small doses of opioids (most commonly fentanyl 10–25 mcg or morphine 100–200 mcg) to enhance the quality and duration of spinal anesthesia. This combination provides synergistic analgesia, allowing a lower dose of bupivacaine to be used while maintaining excellent surgical conditions. The addition of intrathecal opioids is particularly common in obstetric spinal anesthesia for cesarean section and in orthopedic surgery. However, intrathecal opioids carry their own risks, including pruritus (itching), nausea, urinary retention, and delayed respiratory depression (particularly with morphine), which require appropriate postoperative monitoring.
Always provide a complete list of all medications, supplements, and herbal remedies you are taking to your anesthesiologist before the procedure. This includes over-the-counter medications such as aspirin and NSAIDs, herbal supplements (some of which, such as garlic, ginkgo biloba, and ginseng, have antiplatelet properties), and any prescription anticoagulants. This information is essential for safe planning of your spinal anesthetic.
What Is the Correct Dosage of Bupivacaine Spinal Tung Grindeks?
The dosage of Bupivacaine Spinal Tung Grindeks is highly individualized and determined by the anesthesiologist based on multiple factors, including the type and expected duration of surgery, the desired level of sensory and motor block, the patient’s height, weight, age, and overall physical condition, and the patient’s position during and after injection. Unlike many medications taken orally or intravenously, spinal anesthesia requires precise dosing tailored to each individual case, as even small differences in dose can significantly affect the block characteristics.
Adults
| Surgical Procedure | Typical Dose | Volume (5 mg/ml) | Expected Duration |
|---|---|---|---|
| Perineal/Saddle block | 5–7.5 mg | 1–1.5 ml | 1–2 hours |
| Lower extremity surgery | 10–15 mg | 2–3 ml | 2–3 hours |
| Hip replacement | 12.5–17.5 mg | 2.5–3.5 ml | 2–3.5 hours |
| Lower abdominal surgery | 12.5–20 mg | 2.5–4 ml | 2–3.5 hours |
| Cesarean section | 10–12.5 mg | 2–2.5 ml | 1.5–2.5 hours |
| Urological (TURP) | 10–15 mg | 2–3 ml | 2–3 hours |
The maximum recommended single dose for intrathecal administration in adults is 20 mg (4 ml). Doses at the lower end of the range should be used in elderly patients, patients of short stature, pregnant patients, and those with conditions that increase sensitivity to the drug. Higher doses within the recommended range produce a higher block level, longer duration of both sensory and motor block, and a greater degree of motor block.
Children and Adolescents
Spinal anesthesia with bupivacaine can be used in pediatric patients, although it is less common than in adults. In neonates and infants, spinal anesthesia is sometimes used as an alternative to general anesthesia for lower abdominal or lower extremity surgery, particularly in ex-premature infants who are at increased risk of postoperative apnea following general anesthesia. Dosing in children is calculated on a weight basis and is typically 0.3–0.5 mg/kg for infants (under 1 year) and 0.2–0.4 mg/kg for older children. Pediatric spinal anesthesia requires specialized expertise and equipment, and should only be performed by anesthesiologists experienced in pediatric regional anesthesia.
Elderly Patients
Elderly patients require dose reductions due to multiple factors that increase their sensitivity to spinal anesthesia. Age-related changes include reduced CSF volume (due to degeneration of intervertebral discs and epidural fat deposition), increased neural sensitivity to local anesthetics, reduced cardiovascular reserve to compensate for sympathetic blockade, and slower clearance of the drug from the intrathecal space. A dose reduction of approximately 20–30% is typically recommended for patients over 60 years of age. For example, an elderly patient undergoing hip replacement may receive 10–12.5 mg rather than the 15–17.5 mg that might be used in a younger adult of similar height and weight.
Missed Dose
The concept of a missed dose does not apply to Bupivacaine Spinal Tung Grindeks, as it is a single-dose medication administered by a healthcare professional during a surgical procedure. It is not a medication that patients take on a scheduled basis.
Overdose
Overdose of intrathecal bupivacaine is a medical emergency that can result in a high or total spinal block. This manifests as progressive ascending paralysis, respiratory failure (due to paralysis of the intercostal muscles and diaphragm), profound hypotension, and bradycardia that can progress to cardiac arrest. Management is supportive and includes immediate securing of the airway with endotracheal intubation and mechanical ventilation, aggressive intravenous fluid resuscitation, vasopressor administration (epinephrine, phenylephrine, or norepinephrine), and atropine for bradycardia. In cases of cardiac arrest related to bupivacaine systemic toxicity (which is more relevant to inadvertent intravascular injection than to intrathecal overdose), 20% lipid emulsion (Intralipid) should be administered according to established LAST (Local Anesthetic Systemic Toxicity) protocols.
Bupivacaine Spinal Tung Grindeks is never self-administered. It is always given by a qualified anesthesiologist in a fully equipped operating theater or procedure room. The anesthesiologist carefully calculates the dose for each individual patient and has immediate access to resuscitation equipment and emergency medications.
What Are the Side Effects of Bupivacaine Spinal Tung Grindeks?
The side effects associated with Bupivacaine Spinal Tung Grindeks can be divided into two categories: those related to the pharmacological effects of spinal anesthesia (particularly the sympathetic blockade), and those related to the spinal needle puncture procedure itself. It is important to understand that many of the “side effects” of spinal anesthesia are predictable and manageable consequences of the sympathetic nervous system blockade, rather than adverse drug reactions in the traditional sense. Your anesthesia team will be prepared to manage these effects throughout the procedure.
The following side effects have been reported with intrathecal bupivacaine, based on clinical trials, published literature, and post-marketing pharmacovigilance data:
Very Common
May affect more than 1 in 10 people
- Hypotension (low blood pressure) – due to sympathetic blockade and venodilation
- Nausea – often secondary to hypotension or vagal stimulation
- Bradycardia (slow heart rate) – due to blockade of cardiac sympathetic fibers (T1–T4)
Common
May affect up to 1 in 10 people
- Vomiting
- Urinary retention – due to blockade of sacral parasympathetic nerves controlling the bladder
- Post-dural puncture headache (PDPH) – positional headache caused by CSF leak from the dural puncture
- Back pain at the injection site
- Dizziness
Uncommon
May affect up to 1 in 100 people
- Paresthesia (tingling or pins and needles) – usually temporary
- Muscle weakness persisting beyond expected duration
- Shivering (thermoregulatory response to sympathetic blockade)
- High spinal block extending above the intended level
Rare
May affect up to 1 in 1,000 people
- Total spinal block with respiratory paralysis and cardiovascular collapse
- Cardiac arrest
- Spinal epidural hematoma (particularly in patients with coagulation abnormalities)
- Cauda equina syndrome – permanent nerve damage to the cauda equina nerve roots
- Transient neurological symptoms (TNS) – pain or dysesthesia in the buttocks and legs lasting days to weeks
- Arachnoiditis – inflammation of the arachnoid membrane
- Meningitis (aseptic or infectious)
- Allergic reactions to bupivacaine (extremely rare with amide-type local anesthetics)
Hypotension is the most common and most clinically significant hemodynamic effect, occurring in approximately 15–33% of patients receiving spinal anesthesia. It results from the blockade of sympathetic nerve fibers that maintain vascular tone. Risk factors for hypotension include higher block levels, older age, hypovolemia, and use of concurrent antihypertensive medications. Preventive strategies include intravenous fluid preloading or co-loading, left uterine displacement in pregnant patients, and prophylactic vasopressor administration. Treatment involves intravenous fluids and vasopressor agents such as ephedrine or phenylephrine.
Post-dural puncture headache (PDPH) is a characteristic positional headache that typically worsens when sitting or standing and improves when lying flat. It is caused by ongoing leakage of CSF through the dural puncture site, resulting in reduced intracranial CSF pressure. The incidence of PDPH depends largely on the size and type of spinal needle used; modern pencil-point (non-cutting) needles of small gauge (25G or 27G) have significantly reduced the incidence to approximately 1–3% in most patient populations. PDPH is more common in younger patients and women. Most cases resolve spontaneously within 1–2 weeks with conservative management (hydration, caffeine, simple analgesics), but severe or persistent cases may require an epidural blood patch, which is effective in approximately 70–90% of cases.
Serious neurological complications following spinal anesthesia are extremely rare but include cauda equina syndrome (permanent damage to the nerve roots in the lower spinal canal), transient neurological symptoms, and spinal epidural hematoma or abscess. The estimated incidence of permanent neurological injury following spinal anesthesia is approximately 1 in 20,000–50,000 procedures in large registry studies.
After spinal anesthesia, seek urgent medical advice if you experience: severe headache that worsens when sitting or standing and does not respond to simple painkillers; new onset back pain with fever or signs of infection; weakness or numbness in the legs that persists or worsens beyond the expected recovery time; loss of bladder or bowel control after the expected duration of the spinal block has passed. These symptoms may indicate a rare but serious complication that requires prompt evaluation and treatment.
How Should You Store Bupivacaine Spinal Tung Grindeks?
Bupivacaine Spinal Tung Grindeks is a hospital-use medication, and its storage is managed by trained pharmacy and clinical personnel according to institutional protocols and the manufacturer’s instructions. Patients do not typically handle or store this medication themselves. Nevertheless, the following storage requirements are important for maintaining the quality, sterility, and efficacy of the product:
- Temperature: Store at temperatures not exceeding 25°C (77°F). Do not refrigerate or freeze, as extreme temperatures can cause precipitation of the glucose in the hyperbaric solution or alter the physicochemical properties of the formulation.
- Light protection: Keep the ampoules in the outer carton to protect from light, as bupivacaine may undergo photodegradation upon prolonged exposure to light.
- Do not freeze: Freezing can compromise the integrity of the solution and the glass ampoule.
- Visual inspection: Before use, the solution must be visually inspected. It should be a clear, colorless solution free from visible particles. Do not use if the solution is discolored, cloudy, or contains particulate matter, or if the ampoule appears damaged.
- Single use: Each ampoule is for single use only. Any unused solution remaining after the procedure must be discarded and not stored for later use. The solution does not contain antimicrobial preservatives, and reuse could lead to microbial contamination and potentially fatal CNS infection.
- Shelf life: Do not use after the expiration date stated on the ampoule and carton. The expiration date refers to the last day of that month.
- Keep out of reach of children: Although this is a hospital-use product, it must be stored securely and out of reach of unauthorized personnel.
In the operating theater environment, ampoules of bupivacaine should be stored in a designated area, clearly labeled and separated from other medications to prevent drug selection errors. Many institutions use color-coded labels for intrathecal medications to reduce the risk of wrong-route administration, which is a recognized patient safety concern. The solution should be drawn up into the syringe immediately before use under aseptic conditions.
What Does Bupivacaine Spinal Tung Grindeks Contain?
Understanding the composition of Bupivacaine Spinal Tung Grindeks is important for identifying potential allergens and understanding the pharmacological basis of the product’s properties. The formulation is specifically designed for intrathecal use and differs from bupivacaine preparations intended for other routes of administration (such as epidural or peripheral nerve block).
Active Ingredient
The active substance is bupivacaine hydrochloride, an amide-type local anesthetic. Each milliliter of solution contains 5 mg of bupivacaine hydrochloride (equivalent to approximately 4.4 mg of bupivacaine base). Bupivacaine was first synthesized in 1957 by Bo af Ekenstam and colleagues at AB Bofors in Sweden, and it was introduced into clinical practice in the 1960s. It is the S(-) and R(+) racemic mixture; the pure S(-) enantiomer is marketed separately as levobupivacaine, which has a slightly lower cardiotoxicity profile.
Inactive Ingredients (Excipients)
| Ingredient | Amount per ml | Role |
|---|---|---|
| Bupivacaine hydrochloride | 5 mg | Active anesthetic substance |
| Glucose monohydrate | 80 mg | Makes solution hyperbaric (heavier than CSF) |
| Sodium hydroxide / Hydrochloric acid | q.s. | pH adjustment (target pH 4.0–6.5) |
| Water for injections | q.s. to 1 ml | Solvent |
Appearance and Packaging
Bupivacaine Spinal Tung Grindeks is supplied as a clear, colorless solution for injection in 4 ml glass ampoules. Each ampoule contains 4 ml of solution, providing a total of 20 mg of bupivacaine hydrochloride per ampoule. The ampoules are made of clear glass to allow visual inspection of the solution before use. Packs typically contain 5 or 10 ampoules, though pack sizes may vary by country.
Key Formulation Properties
The specific gravity of the solution at 20°C is approximately 1.026, compared with the specific gravity of human cerebrospinal fluid, which is approximately 1.003–1.009. This difference in density is what makes the solution “hyperbaric” and allows it to be influenced by gravity when injected into the subarachnoid space. The solution is preservative-free, which is essential for intrathecal use, as preservatives such as methylparaben can cause neurotoxicity when injected into the subarachnoid space.
Manufacturer
Bupivacaine Spinal Tung Grindeks is manufactured by AS Grindeks, a pharmaceutical company headquartered in Riga, Latvia. Grindeks is one of the largest pharmaceutical manufacturers in the Baltic States and has been producing medications since 1946. The product is manufactured under Good Manufacturing Practice (GMP) standards and is approved for use in multiple European countries.
Frequently Asked Questions About Bupivacaine Spinal Tung Grindeks
“Hyperbaric” means the solution is denser (heavier) than the patient’s cerebrospinal fluid (CSF). This is achieved by adding glucose to the bupivacaine solution. The clinical importance is that a hyperbaric solution sinks to the lowest point in the spinal canal under the influence of gravity. This allows the anesthesiologist to control the spread and level of the spinal block by positioning the patient during and immediately after injection. For example, sitting upright during injection concentrates the block in the sacral region (saddle block), while lying flat allows wider spread. This predictability is a significant advantage compared with isobaric (plain) solutions, whose spread is more variable and less dependent on positioning.
Yes, typically you will be awake or lightly sedated during a procedure under spinal anesthesia. You will not feel pain in the area being operated on, but you may feel some pressure or movement. Many patients find the experience comfortable, and some appreciate being aware during the procedure (for example, during cesarean section, when they can hear their baby’s first cry). If you feel anxious about being awake, your anesthesiologist can provide sedation through your intravenous line to help you relax. In some cases, if the surgery takes longer than expected or if the spinal block is not adequate, conversion to general anesthesia may be necessary.
The duration of the spinal block depends on the dose of bupivacaine used. Typically, sensory block (numbness) resolves within 2–4 hours and motor block (inability to move the legs) resolves within 2–5 hours after injection. The block regresses gradually from the highest level downward. You will usually be able to wiggle your toes first, and then progressively regain movement and sensation in the legs. You will be monitored in the recovery area until the block has adequately regressed. You should not attempt to stand or walk until your motor function has fully returned and you have been assessed by the nursing staff, as there is a risk of falls while the legs are still partially numb or weak.
Before performing the spinal injection, the anesthesiologist will numb the skin at the injection site with a small amount of local anesthetic. This feels like a brief sting, similar to having blood drawn. The spinal needle itself may cause a sensation of pressure or a brief electric-like feeling in the back or down one leg, but this is usually momentary. Most patients describe the procedure as uncomfortable rather than painful, and it typically takes only a few minutes. Modern small-gauge pencil-point spinal needles have significantly improved patient comfort during the procedure and reduced the risk of post-dural puncture headache.
Permanent back pain from spinal anesthesia is not a recognized complication. Temporary back pain or tenderness at the injection site is common and typically resolves within a few days. Permanent neurological injury (including paralysis) is an extremely rare complication, with an estimated incidence of approximately 1 in 20,000–50,000 procedures according to large national and international registries. The most common cause of serious neurological injury following spinal anesthesia is spinal epidural hematoma, which is primarily a risk in patients with coagulation disorders or those receiving anticoagulant therapy. When spinal anesthesia is performed according to established guidelines by experienced practitioners, it is considered a very safe procedure.
A post-dural puncture headache (PDPH) is a headache that develops within 5 days of spinal anesthesia and is characteristically worse when sitting or standing and better when lying flat. It is caused by leakage of cerebrospinal fluid through the hole made by the spinal needle, leading to reduced intracranial pressure. With modern pencil-point needles (25G or smaller), the incidence is low (approximately 1–3%). Most cases are mild and resolve within 1–2 weeks with conservative treatment: bed rest, adequate hydration, caffeine (oral or intravenous), and simple analgesics. If symptoms are severe or do not improve, an epidural blood patch may be offered, which involves injecting a small amount of the patient’s own blood into the epidural space to seal the dural puncture. This is effective in 70–90% of cases.
References
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023. Available at: WHO Essential Medicines.
- European Medicines Agency (EMA). Bupivacaine – Summary of Product Characteristics. Available at: EMA.
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