Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction
2 other identifiers
interventional
120
1 country
1
Brief Summary
The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP block, after breast reconstruction surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedResults Posted
Study results publicly available
September 23, 2021
CompletedSeptember 23, 2021
August 1, 2021
3.9 years
November 4, 2015
June 28, 2021
August 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative Narcotic Usage
Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group.
48 hours
Secondary Outcomes (5)
Post-operative Pain Score
2 days
Post-operative Anti-emetic Usage
48 hours
Time to Ambulation
up to 1 week
Time to First Bowel Movement
up to 1 week
Quality of Life Measurement
Pre-operative Baseline and Post-operative (2-6 months)
Study Arms (2)
0.125% Bupivacaine
EXPERIMENTAL0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Placebo
PLACEBO COMPARATORSaline infusion (sham) via transversus abdominis plane (TAP) catheter.
Interventions
Eligibility Criteria
You may qualify if:
- Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic treatment.
- Greater than 18 years old.
- Female.
- Undergoing microsurgical breast reconstruction with abdominal free flap.
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- True allergy to local anesthetics or opioids.
- History of addiction to narcotics within the last 24 months
- History of chronic pain on opioids within the last 24 months.
- Specific mental health issues such as schizophrenia or bipolar disorder.
- Patients who are pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University Medical Center
Stanford, California, 94305, United States
Related Publications (4)
Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241.
PMID: 28445351BACKGROUNDPusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PMID: 19644246BACKGROUNDVoineskos SH, Klassen AF, Cano SJ, Pusic AL, Gibbons CJ. Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients. Plast Reconstr Surg. 2020 Jan;145(1):11e-20e. doi: 10.1097/PRS.0000000000006317.
PMID: 31577663BACKGROUNDKwong JW, Tijerina JD, Choi S, Shakir A, Nguyen DH, Nazerali RS, Lee GK. Randomized Double-Blinded, Placebo-Controlled Trial: Transversus Abdominis Plane (TAP) Blocks in Breast Cancer Patients Undergoing Reconstruction with Abdominal Free Flap. Annual Meeting of the California Society of Plastic Surgeons. San Diego, California. May 19, 2018.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gordon Kwanlyp Lee, Professor of Surgery (Plastic and Reconstructive Surgery)
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon K Lee, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery (Plastic and Reconstructive Surgery)
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 10, 2015
Study Start
November 1, 2015
Primary Completion
September 7, 2019
Study Completion
June 1, 2021
Last Updated
September 23, 2021
Results First Posted
September 23, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share