Bilateral Transversus Abdominis Plane Block and Postopera... | NCT00964600

Studies
Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery

NCT00964600

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 18, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

TAP blockade

Countries

Iran

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

Aug 20, 2009

First Submission Date that Met QC Criteria

Aug 23, 2009

First Posted Date

Aug 25, 2009Estimated

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

Nov 17, 2010

Last Update Posted Date

Nov 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The patients planned to go under elective cesarean delivery under general anesthesia are randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic requirements are recorded. It's supposed that both are significantly reduced in patients undergoing TAP block.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP blockade	Experimental	bilateral TAP blockade at the end of cesarean delivery	Procedure: TAP blockade
No TAP	No Intervention	These patients would have usual analgesic drugs after cesarean

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAP blockade	Procedure	15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm	TAP blockade

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity after cesarean section		one year

Secondary Outcomes

Measure	Description	Time Frame
Analgesic prescribed measurement		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective cesarean delivery
Term pregnancies
General anesthesia
Pfannenstiel incision

Exclusion Criteria:

No history of sensitivity to prescribed analgesic (Bupivacaine or related substances)
No preeclampsia
No history of psychologic disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laleh Eslamian, MD	Tehran University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sharati hospital	Recruiting	Tehran	Tehran Province	14114	Iran

Type	Date	Date Unknown
Release	Feb 20, 2011
Reset	Mar 16, 2011
Release	Jul 25, 2011
Reset	Aug 17, 2011
Release	Aug 18, 2011
Reset	Sep 20, 2011
Release	Jan 18, 2012
Reset	Feb 16, 2012
Release	May 16, 2014
Reset	Jun 17, 2014

Submission Tracking

Estimated Results First Submitted Date

Feb 20, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 20, 2011			Mar 16, 2011
Jul 25, 2011

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided