NCT03383198

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

December 19, 2017

Results QC Date

September 30, 2020

Last Update Submit

October 28, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Subjective Bilateral Pain Comparison

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

    up to 48 hours

Secondary Outcomes (1)

  • Duration of Analgesia

    up to 48 hours

Study Arms (2)

Liposomal Bupivacaine Left

ACTIVE COMPARATOR

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

Drug: Liposomal bupivacaine left injection

Liposomal Bupivacaine Right

ACTIVE COMPARATOR

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

Drug: Liposomal bupivacaine right injection

Interventions

Liposomal bupivacaine right injectionDRUG

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.

Also known as: Exparel Right
Liposomal Bupivacaine Right
Liposomal bupivacaine left injectionDRUG

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.

Also known as: Exparel Left
Liposomal Bupivacaine Left

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBilateral mastectomy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for bilateral mastectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patewood Memorial Hospital

Greenville, South Carolina, 29615, United States

Location

Related Publications (2)

  • 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.

    PMID: 25376971BACKGROUND

  • 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.

    PMID: 28234636BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Manufacturer discontinued supplying product for the study.

Results Point of Contact

Title
Dr. William R. Hand
Organization
Prisma Health
William.Hand@prismahealth.org
864.522.3707

Study Officials

  • William Hand, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Only anesthesiologist performing injection will be aware of which side is injected with each drug.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

December 1, 2017

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

November 19, 2020

Results First Posted

November 19, 2020

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)