Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section

NCT06290583 | Completed

• 1 other identifier: Prilocaine in cesarean section
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• Maternal arterial blood pressure

  Noninvasive blood pressure will be measured at selected time frame.. Hypotension will be defined as a decrease of systolic blood pressure of at least 20% from baseline. Upon its occurrence, and/or appearance of nausea and dizziness, treatment will be immediately with ephedrine 5mg/ dose

  at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours

Secondary Outcomes (2)

• Evaluation of duration of motor block

  will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression

• Total dose of ephedrine

  From beginning of administration of spinal anesthesia until complete regression of motor blockade

Study Arms (2)

Group B

ACTIVE COMPARATOR

Patients will be given spinal anesthesia with bupivacaine (10 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected.

Drug: Bupivacaine

Group P

ACTIVE COMPARATOR

Patients will be given spinal anesthesia with prilocaine (50 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected.

Drug: Prilocaine

Interventions

Bupivacaine DRUG

Spinal anesthesia with standard dose of bupivacaine

Also known as: Intrathecal Bupivacaine

Group B

Prilocaine DRUG

Spinal anesthesia with 50 mg dose of Prilocaine.

Also known as: Intrathecal prilocaine

Group P

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant \>36 weeks singleton baby
• American Society of Anesthesiologists (ASA) physical status 2
• Age : between 18 years old and 35 years old

You may not qualify if:

• Pregnant women with cardiac disease and history of psychiatric illness
• Pregnant women who received spinal anesthesia and converted to general anesthesia
• Women who have sensitivity to local anesthetics,
• Women who have Eclampsia, abruption placenta or placenta previa
• Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Qina, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Prilocaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohamed G Ahmed, MD

  Lecturer in anesthesiology, intensive care and pain management, South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in anesthesiology, intensive care and pain management

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: April 21, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)