Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-02 @ 12:59 AM
Study NCT ID:
NCT06680167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-08
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Prilocaine 2% vs Hyperbaric Bupivacaine 0.5% in Caesarean Section
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
A Comparative Study Between Hyperbaric Prilocaine 2% Versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 .
Detailed Description:
Patients will be randomly allocated into two groups:
1. Prilocaine Group (Group A):
* Patients will receive 60 mg of hyperbaric prilocaine 2% intrathecally.
* The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique).
* The injection will be performed at the L3-L4 or L4-L5 interspace.
2. Bupivacaine Group (Group B):
* Patients will receive 12.5 mg of hyperbaric bupivacaine 0.5% intrathecally.
* The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique) .
* The injection will be performed at the L3-L4 or L4-L5 interspace.
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
1. Prilocaine Group (Group A):
* Patients will receive 60 mg of hyperbaric prilocaine 2% intrathecally.
* The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique).
* The injection will be performed at the L3-L4 or L4-L5 interspace.
2. Bupivacaine Group (Group B):
* Patients will receive 12.5 mg of hyperbaric bupivacaine 0.5% intrathecally.
* The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique) .
* The injection will be performed at the L3-L4 or L4-L5 interspace.
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: