Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast - Female

Intervention / Treatment
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* Procedure: Transversus Abdominis Plane (TAP) block
* Device: Nimbus Infusion Pump IV Administration
* Drug: Bupivacaine infusion
* Drug: Acetominophen
* Drug: Hydromorphone
* Drug: Oxycodone
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.125% Bupivacaine<br>0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter | Procedure: Transversus Abdominis Plane (TAP) block<br> <br> Device: Nimbus Infusion Pump IV Administration<br> <br> Drug: Bupivacaine infusion<br> <br> * Other names: P-Care M;Drug: Acetominophen<br> <br> * Other names: Tylenol;Drug: Hydromorphone<br> <br> * Other names: Exalgo;Drug: Oxycodone<br> <br> * Other names: Roxicodone;Drug: Ondansetron<br> <br> * Other names: Zuplenz;|
| Placebo Comparator: Placebo<br>Saline infusion (sham) via transversus abdominis plane (TAP) catheter. | Procedure: Transversus Abdominis Plane (TAP) block<br> <br> Device: Nimbus Infusion Pump IV Administration<br> <br> Drug: Acetominophen<br> <br> * Other names: Tylenol;Drug: Hydromorphone<br> <br> * Other names: Exalgo;Drug: Oxycodone<br> <br> * Other names: Roxicodone;Drug: Ondansetron<br> <br> * Other names: Zuplenz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Score | Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation. | 2 days | 
| Post-operative Anti-emetic Usage | Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation. | 48 hours | 
| Time to Ambulation | Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. | up to 1 week | 
| Time to First Bowel Movement | Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. | up to 1 week | 
| Quality of Life Measurement | Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation. | Pre-operative Baseline and Post-operative (2-6 months) |