Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
NCT ID: NCT02601027
Last Updated: 2021-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2015-11-30
2021-06-30
Brief Summary
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Detailed Description
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Secondary Objectives:
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect post-operative pain scores as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect anti-emetic usage as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to ambulation post-operatively as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to first bowel movement as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect patient-reported quality of life as compared to a placebo TAP block.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Transversus Abdominis Plane (TAP) block
Nimbus Infusion Pump IV Administration
Bupivacaine infusion
Acetominophen
Hydromorphone
Oxycodone
Ondansetron
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Transversus Abdominis Plane (TAP) block
Nimbus Infusion Pump IV Administration
Acetominophen
Hydromorphone
Oxycodone
Ondansetron
Interventions
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Transversus Abdominis Plane (TAP) block
Nimbus Infusion Pump IV Administration
Bupivacaine infusion
Acetominophen
Hydromorphone
Oxycodone
Ondansetron
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Gordon Kwanlyp Lee
Professor of Surgery (Plastic and Reconstructive Surgery)
Principal Investigators
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Gordon K Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University Medical Center
Stanford, California, United States
Countries
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References
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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.
Pusic 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.
Voineskos 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.
Kwong 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BRS0058
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-34315
Identifier Type: -
Identifier Source: org_study_id
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