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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
TAP blockade
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring transversus abdominis block, postoperative pain, cesarean

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sharati hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAP blockade

No TAP

Arm Description

bilateral TAP blockade at the end of cesarean delivery

These patients would have usual analgesic drugs after cesarean

Outcomes

Primary Outcome Measures

Pain intensity after cesarean section

Secondary Outcome Measures

Analgesic prescribed measurement

Full Information

First Posted
August 20, 2009
Last Updated
November 17, 2010
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00964600
Brief Title
Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery
Acronym
TAP
Official Title
Evaluation of the Effect of Bilateral Transversus Abdominis Plane Block on Postoperative Pain Intensity and Analgesia Consumption After Elective Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
transversus abdominis block, postoperative pain, cesarean

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP blockade
Arm Type
Experimental
Arm Description
bilateral TAP blockade at the end of cesarean delivery
Arm Title
No TAP
Arm Type
No Intervention
Arm Description
These patients would have usual analgesic drugs after cesarean
Intervention Type
Procedure
Intervention Name(s)
TAP blockade
Intervention Description
15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm
Primary Outcome Measure Information:
Title
Pain intensity after cesarean section
Time Frame
one year
Secondary Outcome Measure Information:
Title
Analgesic prescribed measurement
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laleh Eslamian, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharati hospital
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laleh Eslamian, MD
Phone
+982122585450
Email
leslamian@tums.ac.ir
Phone
+982184902415
Email
laleh.eslamian@gmail.com
First Name & Middle Initial & Last Name & Degree
Laleh Eslamian, MD

12. IPD Sharing Statement

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

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