Postoperative Cesarean Delivery Pain Relief; Diclofenac V... | NCT03039426

Studies
Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

NCT03039426

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Status

Completed

Last Update Posted

Oct 22, 2020Actual

Enrollment

120Actual

Phase

Phase 4

Conditions

Cesarean Delivery

Interventions

Bupivacaine
Diclofenac

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Dec 30, 2017Actual

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Jan 30, 2017

First Posted Date

Feb 1, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2020

Last Update Posted Date

Oct 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Bupivacaine	Experimental	0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration	Drug: Bupivacaine
Group Diclofenac	Active Comparator	diclofenac 75 mg intramuscular, 2 hours postoperation	Drug: Diclofenac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug	0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration	Group Bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Natthida Mekwongtrakarn		Bangkok		10400	Thailand
Rajavithi Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D004008	Diclofenac

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided