Hyperbaric Prilocaine 2% vs Hyperbaric Bupivacaine 0.5% in Caesarean Section

NCT ID: NCT06680167

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2025-12-31

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

Conditions

Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia

Group Type: ACTIVE_COMPARATOR

spinal anesthesia (hyperbaric Prilocaine 2%)

Intervention Type: DRUG

60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section

patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Spinal anesthesia (heavy bupivacaine 0.5%)

Intervention Type: DRUG

12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section

Interventions

Spinal anesthesia (heavy bupivacaine 0.5%)

12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section

Intervention Type: DRUG

spinal anesthesia (hyperbaric Prilocaine 2%)

60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Women aged 18-45 years.

2. Patients with uncomplicated pregnancies.

3. American society of anesthesiologist (ASA) physical status I or II.

4. Height between 155 cm and 175 cm.

5. Written informed consent provided. -

Exclusion Criteria

1. Patients with known allergies to local anesthetics.

2. Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).

3. Severe preeclampsia or eclampsia.

4. Presence of significant comorbidities (e.g., uncontrolled diabetes, hypertension, renal or hepatic dysfunction).

5. History of spinal surgery or significant spinal deformity.

6. Patients who refuse to participate in the study -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Mohamed Abdelgaber

A Comparative Study between Hyperbaric Prilocaine 2% versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospitals

Sohag, Sohag Governorate, Egypt

Countries

Egypt

Other Identifiers

Soh-Med-15-10---6MS

Identifier Type: -

Identifier Source: org_study_id