Liposomal Bupivacaine in Implant Based Breast Reconstruction

December 17, 2020 updated by: Subhas Gupta, MD, PhD, Loma Linda University

Objectives:

  1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
  2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
  3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
  4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
  5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
  2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
  3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
  4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
  5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.

Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.

The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Health System

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

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy

Exclusion Criteria:

  • Women who are unable to give informed consent to participate in this study
  • Women with a documented history of hypersensitivity reactions to local-anesthetic agents
  • Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
  • Women who are currently pregnant
  • Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
  • Women with impaired hepatic function

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Drug: Bupivacaine with epinephrine
Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
Other Names:
  • Marcaine
  • Sensorcaine
Drug: Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Other Names:
  • Roxanol
Drug: Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Other Names:
  • Norco
Drug: Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Other Names:
  • Valium
Experimental: Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Drug: Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Other Names:
  • Roxanol
Drug: Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Other Names:
  • Norco
Drug: Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Other Names:
  • Valium
Drug: Liposomal bupivacaine
Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
Time Frame: Average Pain Scores 24 hours Post-Operatively
Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.
Average Pain Scores 24 hours Post-Operatively
The Effect of Liposomal Bupivacaine on Antiemetic Consumption
Time Frame: 24 hours
The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.
24 hours
The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
Time Frame: 24 hours
Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.
24 hours
The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
Time Frame: 24 hours
Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.
24 hours
The Effect of Liposomal Bupivacaine on Length of Hospital Stay
Time Frame: 24-60 hours
Length of hospital stay will be determined for patients in each group, in total hours.
24-60 hours

Collaborators and Investigators

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

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Subhas C. Gupta, MD, PhD, Loma Linda University
  • Study Director: Wendy W. Wong, MD, Loma Linda University

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)

July 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5150012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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