Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Phase 4

Completed

• Conditions: Cesarean Delivery
• Interventions: Drug: Bupivacaine; Drug: Diclofenac

• Registration Number: NCT03039426
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-09-28
• Study Start: 2017-01-01
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2017-06-30
• Status Verified: 2017-10
• Study Completion: 2017-12-30
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Natthida Mekwongtrakarn; 🇹🇭 Bangkok, Thailand

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand