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

Not Applicable

Completed

• Conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
• Interventions: Drug: Bupivacaine; Drug: Prilocaine

• Registration Number: NCT06290583
• Lead Sponsor: South Valley University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Study Start: 2024-04-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Bupivacaine	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.
Group P	Prilocaine	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.

Primary Outcome Measures

Name	Time	Method
Maternal arterial blood pressure	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	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

Secondary Outcome Measures

Name	Time	Method
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	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).
Total dose of ephedrine	From beginning of administration of spinal anesthesia until complete regression of motor blockade	When hypotension occurred postspinal ephedrine 5mg per dose will be given to restore blood pressure to 90% of its baseline value.

Trial Locations

Locations (1)

South Valley University; 🇪🇬 Qena, Egypt