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

A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

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.

Study Overview

• Status: Terminated
• Conditions: Mammaplasty
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivicaine HCL

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Bupivicaine; -TAP block of 30 cc of 0.25% bupivicaine	Drug: Bupivicaine HCL; Other Names: Bupivicaine
Experimental: Group 2: Liposomal bupivacaine; -TAP block of 266 mg/30 cc liposomal bupivacaine	Drug: Liposomal bupivacaine; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)
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 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 Pain Scores	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	12 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores	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	24 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores	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	48 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores	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	72 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery	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	At post operative day 2, discharge, and at 1-2 week follow-up
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2016
• Primary Completion (Actual): February 26, 2018
• Study Completion (Actual): March 8, 2018

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 201601064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No