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

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ClinicalTrials.gov Identifier: NCT00964600
Recruitment Status : Unknown
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 25, 2009
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: TAP blockade Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. Pain intensity after cesarean section [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Analgesic prescribed measurement [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laleh Eslamian, MD ,associate Prof
ClinicalTrials.gov Identifier: NCT00964600     History of Changes
Other Study ID Numbers: 825
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms