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
Recruitment status was Recruiting
Sponsor:
Tehran University of Medical Sciences
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 20, 2009 | ||||
| Last Updated Date | November 17, 2010 | ||||
| Start Date ICMJE | September 2008 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain intensity after cesarean section [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00964600 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Analgesic prescribed measurement [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery | ||||
| Official Title ICMJE | Evaluation of the Effect of Bilateral Transversus Abdominis Plane Block on Postoperative Pain Intensity and Analgesia Consumption After Elective Cesarean Delivery | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Postoperative Pain | ||||
| Intervention ICMJE | Procedure: TAP blockade
15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | October 2009 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00964600 | ||||
| Other Study ID Numbers ICMJE | 825 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Laleh Eslamian, MD ,associate Prof | ||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tehran University of Medical Sciences | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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