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Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine right injection
Liposomal bupivacaine left injection
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Scheduled for bilateral mastectomy

Exclusion Criteria:

  • allergy to local anesthetics, prior breast surgery, asymmetric surgical plan

Sites / Locations

  • Patewood Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liposomal Bupivacaine Left

Liposomal Bupivacaine Right

Arm Description

Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right

Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left

Outcomes

Primary Outcome Measures

Subjective Bilateral Pain Comparison
Subjective, binary question "Does one side of your chest have more surgical pain than the other?"

Secondary Outcome Measures

Duration of Analgesia
Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale

Full Information

First Posted
December 19, 2017
Last Updated
October 28, 2020
Sponsor
Prisma Health-Upstate
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1. Study Identification

Unique Protocol Identification Number
NCT03383198
Brief Title
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
Official Title
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine Plus Dexamethasone for Mastectomy With Immediate Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Early termination due to manufacturer discontinued supplying the product for the study.
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.
Detailed Description
This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Only anesthesiologist performing injection will be aware of which side is injected with each drug.
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine Left
Arm Type
Active Comparator
Arm Description
Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right
Arm Title
Liposomal Bupivacaine Right
Arm Type
Active Comparator
Arm Description
Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine right injection
Other Intervention Name(s)
Exparel Right
Intervention Description
Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine left injection
Other Intervention Name(s)
Exparel Left
Intervention Description
Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Primary Outcome Measure Information:
Title
Subjective Bilateral Pain Comparison
Description
Subjective, binary question "Does one side of your chest have more surgical pain than the other?"
Time Frame
up to 48 hours
Secondary Outcome Measure Information:
Title
Duration of Analgesia
Description
Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale
Time Frame
up to 48 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Bilateral mastectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Scheduled for bilateral mastectomy Exclusion Criteria: allergy to local anesthetics, prior breast surgery, asymmetric surgical plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Hand, MD
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patewood Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25376971
Citation
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Results Reference
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PubMed Identifier
28234636
Citation
Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.
Results Reference
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Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery

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