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

July 28, 2021 updated by: Saleh Kanawati, Makassed General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • Makassed General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sufentanil Group
Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
Drug: sufentanil
Patients will receive sufentanil in spinal anesthesia
Drug: Bupivacaine
Patients will receive 0.5% heavy bupivacaine in spinal anesthesia
EXPERIMENTAL: Meperidine Group
Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia
Drug: Bupivacaine
Patients will receive 0.5% heavy bupivacaine in spinal anesthesia
Drug: meperidine
Patients will receive meperidine in spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First analgesic request time
Time Frame: 24 hours post operatively
The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand
24 hours post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic requirements
Time Frame: 24 hours post operatively
A questionnaire will be used to record the analgesics consumed by the patients
24 hours post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makassed General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (ACTUAL)

June 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17062020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Analgesia

Clinical Trials on sufentanil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe