Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

October 20, 2020 updated by: Rajavithi Hospital

A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery

This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

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

  • Thailand
      • Bangkok, Thailand
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Natthida Mekwongtrakarn

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017

    • Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor
  • Pregnant women more than 20 years of age
  • Gestational age more than 37 week
  • Cesarean section under regional or general anesthesia
  • Ability to communicating, writing and reading Thai language

Exclusion Criteria:

  • Inability to communicating or writing or reading Thai language
  • Contraindicated to bupivacaine or diclofenac or morphine
  • Pregnant women with emergency conditions
  • Have one or more complication of pregnancy
  • Intraoperative arrhythmia
  • Pregnant women less than 20 years of age
  • Regional anesthesia with morphine

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Bupivacaine
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
Drug: Bupivacaine
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
Active Comparator: Group Diclofenac
diclofenac 75 mg intramuscular, 2 hours postoperation
Drug: Diclofenac
diclofenac 75 mg intramuscular, 2 hours postoperation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale
Time Frame: 2, 6 and 24 hours post-operation
2, 6 and 24 hours post-operation
Compared rescued dose of morphine injection
Time Frame: Within 24 hours post-operation
Within 24 hours post-operation

Collaborators and Investigators

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

Sponsor

Rajavithi Hospital

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)

January 1, 2017

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBUPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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