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

Prisma Health-Upstate

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Liposomal bupivacaine right injection; Drug: Liposomal bupivacaine left injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03383198

Pro00072519

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Scheduled for bilateral mastectomy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups

Liposomal Bupivacaine Left

Active Comparator group

Description:

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

Treatment:

Drug: Liposomal bupivacaine left injection

Liposomal Bupivacaine Right

Active Comparator group

Description:

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

Treatment:

Drug: Liposomal bupivacaine right injection