Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery (TAP)

November 17, 2010 updated by: Tehran University of Medical Sciences

Evaluation of the Effect of Bilateral Transversus Abdominis Plane Block on Postoperative Pain Intensity and Analgesia Consumption After Elective Cesarean Delivery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Elective cesarean delivery
  2. Term pregnancies
  3. General anesthesia
  4. Pfannenstiel incision

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP blockade
bilateral TAP blockade at the end of cesarean delivery
Procedure: TAP blockade
15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm
No Intervention: No TAP
These patients would have usual analgesic drugs after cesarean

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity after cesarean section
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Analgesic prescribed measurement
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Laleh Eslamian, MD, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 23, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 825

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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