Status:
COMPLETED
TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Society of Plastic Surgeons
The Plastic Surgery Foundation
Conditions:
Transversus Abdominis Plane (TAP) Block Catheter
DIEP or Free MS-TRAM Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety...
Detailed Description
1\. Statement of Objectives/Specific Aims The transversus abdominis plane (TAP) block is a newly developed block involving T6-L1 nerves that supply the anterior abdominal wall. Its effectiveness has ...
Eligibility Criteria
Inclusion
- Pre-operative eligibility:
- Patients above the age of 18, no upper age limit
- English-speaking
- Delayed reconstruction (mastectomy already performed) or immediate reconstruction (mastectomy at the same time as reconstruction)
- Reconstruction using abdominal tissues including free MS-TRAM or DIEP
Exclusion
- Patient refusal
- Inability to give informed consent
- BMI \> 40
- Allergy to Bupivacaine
- Known cardiac or liver disease (contraindicated for Bupivacaine use)
- Patients who will undergo any of the following:
- Implant breast reconstruction
- Combined implant and autologous tissue reconstruction
- Non-abdominally based autologous tissue reconstruction
- Nonmicrosurgical abdominally based breast reconstruction (pedicled TRAM flap)
- Drug addiction
- Opioid tolerance defined as preoperative opioid use of \>50 mg PO morphine equivalent
- Psychiatric illness
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01398982
Start Date
July 1 2011
End Date
February 1 2014
Last Update
April 1 2015
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4