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

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The Washington University

Status and phase

Terminated
Phase 4

Conditions

Mammaplasty

Treatments

Drug: Liposomal bupivacaine
Drug: Bupivicaine HCL

Study type

Interventional

Funder types

Other

Identifiers

NCT02662036
201601064

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Group 1: Bupivicaine
Active Comparator group
Description:
-TAP block of 30 cc of 0.25% bupivicaine
Treatment:
Drug: Bupivicaine HCL
Group 2: Liposomal bupivacaine
Experimental group
Description:
-TAP block of 266 mg/30 cc liposomal bupivacaine
Treatment:
Drug: Liposomal bupivacaine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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