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

Mammaplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02662036
• Other study ID #: 201601064
• Status: Terminated
• Phase: Phase 4
• Start date: February 29, 2016
• Est. completion date: March 8, 2018

Study information

• Verified date: February 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: March 8, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mammaplasty

Intervention

Drug:
• Bupivicaine HCL

• Liposomal bupivacaine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation		Up to 2 weeks post-operation
Secondary	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter		Up to 2 weeks post-operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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