NCT02662036

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 29, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

January 20, 2016

Results QC Date

January 16, 2019

Last Update Submit

February 13, 2019

Conditions

Mammaplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

    12 hours after surgery

  • +5 more secondary outcomes

Study Arms (2)

Group 1: Bupivicaine

ACTIVE COMPARATOR

-TAP block of 30 cc of 0.25% bupivicaine

Drug: Bupivicaine HCL

Group 2: Liposomal bupivacaine

EXPERIMENTAL

-TAP block of 266 mg/30 cc liposomal bupivacaine

Drug: Liposomal bupivacaine

Interventions

Bupivicaine HCLDRUG
Also known as: Bupivicaine
Group 1: Bupivicaine
Liposomal bupivacaineDRUG
Also known as: Exparel
Group 2: Liposomal bupivacaine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

Results Point of Contact

Title
Terence Myckatyn, M.D.
Organization
Washington University School of Medicine
myckatyn@wustl.edu
314-996-8800

Study Officials

  • Terence Myckatyn, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 25, 2016

Study Start

February 29, 2016

Primary Completion

February 26, 2018

Study Completion

March 8, 2018

Last Updated

February 18, 2019

Results First Posted

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)