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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00964600
First received: August 20, 2009
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Procedure: TAP blockade

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Bilateral Transversus Abdominis Plane Block on Postoperative Pain Intensity and Analgesia Consumption After Elective Cesarean Delivery

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Pain intensity after cesarean section [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesic prescribed measurement [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964600

Locations
Iran, Islamic Republic of
Sharati hospital Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Laleh Eslamian, MD     +982122585450     leslamian@tums.ac.ir    
Contact     +982184902415     laleh.eslamian@gmail.com    
Principal Investigator: Laleh Eslamian, MD            
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Laleh Eslamian, MD Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Laleh Eslamian, MD ,associate Prof
ClinicalTrials.gov Identifier: NCT00964600     History of Changes
Other Study ID Numbers: 825
Study First Received: August 20, 2009
Last Updated: November 17, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
transversus abdominis block
postoperative pain
cesarean

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013