Clinical trial NCT02601027: Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast - Female
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Primary Objective: The primary objective is to determine if pre-operative transversus abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively affect post-operative narcotic usage as compared to a placebo TAP block.

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.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Post-operative Narcotic Usage
timeFrame: 48 hours
Secondary outcomes:
measure: Post-operative Pain Score
timeFrame: 2 days
measure: Post-operative Anti-emetic Usage
timeFrame: 48 hours
measure: Time to Ambulation
timeFrame: up to 1 week
measure: Time to First Bowel Movement
timeFrame: up to 1 week
measure: Quality of Life Measurement
timeFrame: Pre-operative Baseline and Post-operative (2-6 months)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Gordon K Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.