Clinical trial NCT02662036: Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
Official title: A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mammaplasty
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 70
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: This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
* At least 18 years of age.
* Female.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Cognitive impairment.
* History of abdominal surgery precluding free flap donor site.
* Allergy or intolerance to bupivacaine or "amide" anesthetics.
* Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
* Pregnant or breastfeeding.

Primary outcomes:
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
timeFrame: Up to day of discharge from hospital (expected hospital stay of 5 days)
Secondary outcomes:
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
timeFrame: Up to day of discharge from hospital (expected hospital stay of 5 days)
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
timeFrame: Up to day of discharge from hospital, up to 7 days
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
timeFrame: Up to 2 weeks post-operation
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
timeFrame: Up to 2 weeks post-operation
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
timeFrame: 12 hours after surgery
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
timeFrame: 24 hours after surgery
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
timeFrame: 48 hours after surgery
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
timeFrame: 72 hours after surgery
measure: Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
timeFrame: At post operative day 2, discharge, and at 1-2 week follow-up
measure: Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
timeFrame: Up to 2 weeks post-operation
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Terence Myckatyn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: