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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Bupivacaine; Drug: Prilocaine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qena, Egypt
    • South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B; 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; Spinal anesthesia with standard dose of bupivacaine; Other Names: Intrathecal Bupivacaine
Active Comparator: Group P; 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; Spinal anesthesia with 50 mg dose of Prilocaine.; Other Names: Intrathecal prilocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of duration of motor block	the time to motor block regression (duration of motor block), defined as the time between complete block (score 1) after induction of prilocaine or bupivacaine and no motor block (score 6) on the Modified Bromage scale (1, complete motor block; 2, almost complete motor block, ability to move the feet only; 3, ability to move the knees; 4, ability to raise the leg but unable to keep it raised; 5, ability to keep the leg raised for 10 s; 6, no weakness).	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	When hypotension occurred postspinal ephedrine 5mg per dose will be given to restore blood pressure to 90% of its baseline value.	From beginning of administration of spinal anesthesia until complete regression of motor blockade

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Principal Investigator: Mohamed G Ahmed, MD, Lecturer in anesthesiology, intensive care and pain management, South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Prilocaine
• Other Study ID Numbers: Prilocaine in cesarean section

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No