Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-03-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Mammaplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1: Bupivicaine

-TAP block of 30 cc of 0.25% bupivicaine

Group Type ACTIVE_COMPARATOR

Bupivicaine HCL

Intervention Type DRUG

Group 2: Liposomal bupivacaine

-TAP block of 266 mg/30 cc liposomal bupivacaine

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

Interventions

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Bupivicaine HCL

Intervention Type DRUG

Liposomal bupivacaine

Intervention Type DRUG

Other Intervention Names

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Bupivicaine Exparel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No