MedDataX Logo

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

NCT ID: NCT03383198

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Only anesthesiologist performing injection will be aware of which side is injected with each drug.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Liposomal Bupivacaine Left

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

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine left injection

Intervention Type DRUG

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.

Liposomal Bupivacaine Right

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

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine right injection

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liposomal bupivacaine right injection

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

Liposomal bupivacaine left injection

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exparel Right Exparel Left

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled for bilateral mastectomy

Exclusion Criteria

* allergy to local anesthetics, prior breast surgery, asymmetric surgical plan
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Hand, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Patewood Memorial Hospital

Greenville, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25376971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28234636 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00072519

Identifier Type: -

Identifier Source: org_study_id