The Use Of Liposomal Bupivacaine For Pain Control

October 26, 2022 updated by: Wake Forest University Health Sciences

The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction

The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
  • Age ≥ 18 years
  • Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
  • Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.

Exclusion Criteria:

  • Patients who receive an autologous tissue reconstruction.
  • Patients who receive a unilateral reconstruction.
  • Patients who are expected to undergo axillary lymph node dissection
  • Patients who have undergone breast irradiation
  • Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
  • Patients who are wards of the state
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
  • Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
  • Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
  • Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
  • Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine Group
Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
Drug: Bupivacaine
While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Other Names:
  • Marcaine
Experimental: Liposomal Bupivacaine Group
Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
Drug: Liposomal Bupivacaine
While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Visual Analog Scores
Time Frame: 48 hours
This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)
Time Frame: 48 hours
This will be measured during first 48 hours postoperatively
48 hours
Number of Morphine Doses Across All Subjects
Time Frame: 1 Month
This will be measured by the number of doses within the first month postoperatively and recorded on pain medication daily diary kept by subject.
1 Month
Length of Stay for Hospitalization
Time Frame: up to 47 Hours
The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.
up to 47 Hours
Readmission Rates to the Hospital
Time Frame: Month 2
Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded
Month 2
Frequency of Postoperative Opioid Related Adverse Effects
Time Frame: Postoperatively, 1 week
Frequency of postoperative opioid related adverse effects within the first week of surgery will be recorded. This includes nausea, vomiting, pruritus, allergy, respiratory depression.
Postoperatively, 1 week
Pain Intensity With Movement
Time Frame: Up to 2 months
This will be measured by using the Pain Assessment Questionnaire. Total scores are 0-50 with higher scores denoting worse outcomes.
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Christopher M Runyan, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2018

Primary Completion (Actual)

January 29, 2020

Study Completion (Actual)

January 29, 2020

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00045562

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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