Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Overview

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

Full Title of Study: “A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2017

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.

Interventions

  • Drug: Bupivacaine
    • 0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
  • Drug: Diclofenac
    • diclofenac 75 mg intramuscular, 2 hours postoperation

Arms, Groups and Cohorts

  • Experimental: Group 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Compared rescued dose of morphine injection
    • Time Frame: Within 24 hours post-operation

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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