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

Phase 4

Terminated

• Conditions: Mammaplasty
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivicaine HCL

• Registration Number: NCT02662036
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Study Start: 2016-02-29
• Primary Completion: 2018-02-26
• Study Completion: 2018-03-08
• Results First Submitted: 2019-01-16
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Results First Posted: 2019-02-18
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Liposomal bupivacaine	Liposomal bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Group 1: Bupivicaine	Bupivicaine HCL	-TAP block of 30 cc of 0.25% bupivicaine

Primary Outcome Measures

Name	Time	Method
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay	Up to day of discharge from hospital (expected hospital stay of 5 days)

Secondary Outcome Measures

Name	Time	Method
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay	Up to day of discharge from hospital (expected hospital stay of 5 days)
Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics	Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay	Up to day of discharge from hospital, up to 7 days
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores	72 hours after surgery	* Pain scale uses Wong-Baker FACES Pain Rating Scale; * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation	Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter	Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery	At post operative day 2, discharge, and at 1-2 week follow-up	* Quality of Recovery -15 questionnaire; * Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time; * Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time.; * The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States