Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
Stopped early · Phase 4
Conditions studied: Mammaplasty
In brief
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.
Key facts
- Study ID
- NCT02662036
- Run by
- Washington University School of Medicine
- People needed
- 70
- Starts
- 2016-02-29
- Expected to finish
- 2018-03-08
- Last updated by the study team
- 2019-02-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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