Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Cesarean Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039426
• Other study ID #: RJBUPI
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: October 2017
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

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

Locations

Country	Name	City	State
Thailand	Natthida Mekwongtrakarn	Bangkok
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Compared rescued dose of morphine injection		Within 24 hours post-operation