Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Sponsor

Rajavithi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03039426

Collaborator

(none)

120

Enrollment

Locations

Arms

11.9

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery	Drug: Bupivacaine Drug: Diclofenac	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Dec 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]
Compared rescued dose of morphine injection [Within 24 hours post-operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Natthida Mekwongtrakarn	Bangkok		Thailand	10400
2	Rajavithi Hospital	Bangkok		Thailand

Sponsors and Collaborators

Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rajavithi Hospital

ClinicalTrials.gov Identifier:

NCT03039426

Other Study ID Numbers:

RJBUPI

First Posted:

Feb 1, 2017

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Diclofenac

Bupivacaine

Study Results

No Results Posted as of Oct 22, 2020