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Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .
Patients will be randomly allocated into two groups:
Prilocaine Group (Group A):
Bupivacaine Group (Group B):
Procedure Details:
Prior to the procedure, patients will be preloaded with 500 ml of balanced crystalloid solution intravenously. Patients will be positioned in the sitting position for the spinal injection.
The chosen interspace (L3-L4 or L4-L5) will be identified, and the skin will be prepared with an antiseptic solution. A 25 Gauge spinal needle will be used for the intrathecal injection (midline or paramedian technique). After confirming free flow of cerebrospinal fluid, the prepared anesthetic solution will be injected over 10-15 seconds. Following the injection, patients will be placed supine with a slight left lateral tilt to avoid aortocaval compression. The sensory block level will be assessed using Pinprick sensation test, and the motor block will be evaluated using the modified Bromage scale. 5 Blood pressure and heart rate will be monitored every 5 mins until the end of the surgery. In case of hypotension (systolic BP < 90 mmHg or diastolic BP < 60 mmHg), intravenous boluses of 10 mg ephedrine will be administered until blood pressure stabilizes. In case of Bradycardia with Heart rate <55 bpm atropine sulphate 0.01 mg/kg will be given intravenous. Pain Assessment will be done postoperatively via Visual analogue score (VAS) as following if score 3 or less no analgesia required if score 4-5, 1g paracetamol iv will be given if score 6-7, 30mg ketorolac iv will be given if score 7 or more, 2.5mg morphine sulphate iv will be given
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia | Active Comparator |
| |
| patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anesthesia (heavy bupivacaine 0.5%) | Drug | 12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section | 12 HOURS | |
| 2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University Hospitals | Sohag | Sohag Governorate | 82749 | Egypt |
for risk of participant data identification and for privacy concerns
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2026 | |
| Reset | Jun 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2026 | Jun 25, 2026 |
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| spinal anesthesia (hyperbaric Prilocaine 2%) | Drug | 60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section |
|