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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. The completion date has passed and the status has not been verified in more than two years.
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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


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

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

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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on June 23, 2017