Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

July 21, 2020 updated by: Case Comprehensive Cancer Center

Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction

The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy.

OBJECTIVES

  1. Compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. Compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block.
  2. Examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake.
  3. Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients scheduled to have a unilateral, immediate breast reconstruction

Exclusion Criteria:

  • Pregnant

  • Concurrent or recent medical condition that could interfere with study participation including:

    • Hepatitis
    • Alcohol/substance abuse
    • Uncontrolled psychiatric disorders
    • Known allergy
    • Contraindication to amide-type local anesthetics, opioids, or propofol.
  • Body weight of less than 50 kg
  • Participated in another study involving an investigational medication within the prior 30 days
  • Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Liposomal Bupivacaine + Bupivacaine
This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Drug: Liposomal Bupivacaine
20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.
Other Names:
  • Exparel
Drug: Bupivacaine
20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcaine Spinal
  • Sensorcaine-MPF
  • P-Care M
  • Sensorcaine-Methyl Paraben Free (MPF) Spinal
  • ReadySharp Bupivacaine
  • Marcaine Preservative Free
  • Bupivacaine Spinal
Drug: Patient-Controlled Analgesia Pump
The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
Other Names:
  • intravenous narcotic
Drug: Oral Narcotic
Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
Active Comparator: Bupivacaine
This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Drug: Bupivacaine
20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcaine Spinal
  • Sensorcaine-MPF
  • P-Care M
  • Sensorcaine-Methyl Paraben Free (MPF) Spinal
  • ReadySharp Bupivacaine
  • Marcaine Preservative Free
  • Bupivacaine Spinal
Drug: Patient-Controlled Analgesia Pump
The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
Other Names:
  • intravenous narcotic
Drug: Oral Narcotic
Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
total post-operative narcotic utilization
Time Frame: Up to 72 hours post-operative
post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.
Up to 72 hours post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
at rest pain score on visual analog scale
Time Frame: Up to 72 hours post-operative
0-100 score of self-reported pain
Up to 72 hours post-operative
coughing pain score on visual analog scale
Time Frame: Up to 72 hours post-operative
0-100 score of self-reported pain
Up to 72 hours post-operative
number of incidents of nausea reported by patient
Time Frame: Up to 72 hours post-operative
self-report of nausea
Up to 72 hours post-operative
number of incidents of vomiting reported by patient
Time Frame: Up to 72 hours post-operative
number of times a patient vomits
Up to 72 hours post-operative
time to first ambulation
Time Frame: Up to 72 hours post-operative
Up to 72 hours post-operative
time to first liquid intake
Time Frame: Up to 72 hours post-operative
Up to 72 hours post-operative
time to first solid intake
Time Frame: Up to 72 hours post-operative
Up to 72 hours post-operative

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Risal Djohan, MD, Cleveland Clinic, Case Comprehensive Cancer Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASE10117

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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