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
1 other identifier
interventional
120
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2017
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedOctober 22, 2020
October 1, 2017
6 months
September 28, 2016
October 20, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group Bupivacaine
EXPERIMENTAL0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
Group Diclofenac
ACTIVE COMPARATORdiclofenac 75 mg intramuscular, 2 hours postoperation
Interventions
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Natthida Mekwongtrakarn
Bangkok, 10400, Thailand
Rajavithi Hospital
Bangkok, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2016
First Posted
February 1, 2017
Study Start
January 1, 2017
Primary Completion
June 30, 2017
Study Completion
December 30, 2017
Last Updated
October 22, 2020
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share