Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

August 28, 2018 updated by: Sarah Safwat, Ain Shams University

Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial

The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2
  • Phase 3

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

  • Egypt
    • Abbaseya
      • Cairo, Abbaseya, Egypt, 002
        • Ain Shams Maternity 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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mode of delivery: Cesarean section.
  • Gestational age: 37-40 weeks.
  • Type of anaesthesia: Spinal anaesthesia.
  • No past history of any medical disorder or other medical complications during pregnancy.

Exclusion Criteria:

  • Women with known hypersensitivity to bupivacaine or pethidine.
  • Women delivered vaginally.
  • Women delivered under general anaesthesia.
  • Women with known neurological or psychological disease.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine Group
Patients delivered by cesarean section followed by wound infiltration by bupivacaine.
Drug: Wound infiltration by Bupivacaine
Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound
Active Comparator: Pethidine Group
Patients delivered by cesarean section followed by wound infiltration by pethidine.
Drug: Wound infiltration by Pethidine
Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative wound pain: VAS
Time Frame: first 24 hours postoperatively
Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups
first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of opioid drugs needed
Time Frame: first 24 hours postoperatively
Total dose of extra opioid drugs needed to achieve postoperative analgesia
first 24 hours postoperatively
Incidence of nausea and vomiting
Time Frame: first 24 hours postoperatively
Number of patients experiencing nausea and vomiting
first 24 hours postoperatively
Incidence of urine retention
Time Frame: first 24 hours postoperatively
Number of patients experiencing urinary retention
first 24 hours postoperatively
Incidence of hypotension
Time Frame: first 24 hours postoperatively
Number of patients experiencing hypotension
first 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Mohamed Samy, MD, M Samy

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)

April 21, 2017

Primary Completion (Actual)

June 10, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PostCSLA

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.

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