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Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Primary Purpose

Postoperative Pain, Breast Reconstruction

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine TAP block
Bupivacain
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring TAP block, Regional block, ERAS, liposomal bupivacaine, free flap

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Exclusion Criteria:

  • Subjects with ages <18 years

    • Allergy to local anesthetic
    • Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason
    • Subjects who cannot read or understand English
    • Subjects who are pregnant

Sites / Locations

  • University of Virginia Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control - plain bupivacaine

Experimental - Liposomal bupivacaine

Arm Description

Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively

Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively

Outcomes

Primary Outcome Measures

post-op pain scores during initial hospitalization
Visual analog pain scale (0-10)
post-op narcotic pain medication use during hospitalization
total amount of morphine milliequivalent
post-op narcotic pain medication use after discharge (within 30 days of discharge)
total amount of morphine milliequivalent

Secondary Outcome Measures

Length of hospital stay
hospital length of stay
Incidence of Post-op nausea and vomiting (PONV)
Incidence of PONV

Full Information

First Posted
February 23, 2021
Last Updated
March 1, 2021
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04777591
Brief Title
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Official Title
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 10, 2021 (Anticipated)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Reconstruction
Keywords
TAP block, Regional block, ERAS, liposomal bupivacaine, free flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control - plain bupivacaine
Arm Type
Active Comparator
Arm Description
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Arm Title
Experimental - Liposomal bupivacaine
Arm Type
Experimental
Arm Description
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine TAP block
Intervention Description
Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
Primary Outcome Measure Information:
Title
post-op pain scores during initial hospitalization
Description
Visual analog pain scale (0-10)
Time Frame
During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Title
post-op narcotic pain medication use during hospitalization
Description
total amount of morphine milliequivalent
Time Frame
during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Title
post-op narcotic pain medication use after discharge (within 30 days of discharge)
Description
total amount of morphine milliequivalent
Time Frame
from the time of discharge to 30 days post discharge
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
hospital length of stay
Time Frame
during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Title
Incidence of Post-op nausea and vomiting (PONV)
Description
Incidence of PONV
Time Frame
during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center Exclusion Criteria: Subjects with ages <18 years Allergy to local anesthetic Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason Subjects who cannot read or understand English Subjects who are pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel H Park, MD
Phone
5714287278
Email
rhp7gu@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Stranix, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

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