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

Phase 4

Terminated

• Conditions: Pain, Postoperative
• Interventions: Drug: Liposomal bupivacaine left injection; Drug: Liposomal bupivacaine right injection

• Registration Number: NCT03383198
• Lead Sponsor: Prisma Health-Upstate

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Status Verified: 2018-08
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Results First Submitted: 2020-09-30
• Results First Submitted QC: 2020-10-28
• Last Update Submitted: 2020-10-28
• Results First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• Scheduled for bilateral mastectomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine Left	Liposomal bupivacaine left injection	Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right
Liposomal Bupivacaine Right	Liposomal bupivacaine right injection	Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left

Primary Outcome Measures

Name	Time	Method
Subjective Bilateral Pain Comparison	up to 48 hours	Subjective, binary question "Does one side of your chest have more surgical pain than the other?"

Secondary Outcome Measures

Name	Time	Method
Duration of Analgesia	up to 48 hours	Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale

Trial Locations

Locations (1)

Patewood Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States