Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section

Not Applicable

• Conditions: Analgesia
• Interventions: Drug: sufentanil; Drug: meperidine; Drug: Bupivacaine

• Registration Number: NCT04446715
• Lead Sponsor: Makassed General Hospital

Brief Summary

Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged.

In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.

Detailed Description

A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Study Start: 2020-10-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-30
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• pregnant women with American Society of Anesthesiologist (ASA) 2-3
• scheduled for elective cesarean section.

Exclusion Criteria

• refuse to participate in the study,
• requiring emergency obstetric care,
• ASA IV or V,
• having systemic diseases,
• a known fetal anomaly,
• placenta previa,
• abruption placenta
• with a history of hypersensitivity or allergy to any of the study drugs,
• operation time longer than 1.5 hour,
• blood loss more than 1500 millilitres,
• those with any contraindication to the technique proposed,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil Group	sufentanil	Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
Sufentanil Group	Bupivacaine	Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
Meperidine Group	Bupivacaine	Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia
Meperidine Group	meperidine	Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia

Primary Outcome Measures

Name	Time	Method
First analgesic request time	24 hours post operatively	The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand

Secondary Outcome Measures

Name	Time	Method
Analgesic requirements	24 hours post operatively	A questionnaire will be used to record the analgesics consumed by the patients

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon