Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03039426

Enrollment

120

Registered

2017-02-01

Start date

2017-01-01

Completion date

2017-12-30

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery

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.

Interventions

DRUGBupivacaine

0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration

DRUGDiclofenac

diclofenac 75 mg intramuscular, 2 hours postoperation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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

Design outcomes

Primary

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	2, 6 and 24 hours post-operation
Compared rescued dose of morphine injection	Within 24 hours post-operation

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026