Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine.

This is a prospective randomized, double-blinded, controlled trial that will enroll 120 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnny K. Lee
• Collaborator: NorthShore University HealthSystem
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Subject ages 18-90 years old

• Male or Female subjects

• Weight ≥ 60 kg.

• Must be able to consent in English

Exclusion Criteria:

• Ages: <18 and >90

• Weight < 60 kg

• Multiple surgeries during one hospital stay

• Emergency surgery

• Allergy or any contraindication to local anesthetics used in trial.

• Pregnancy

• Contraindicated for use of liposomal bupivacaine

• Severe liver/kidney disease

• Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis

• Subject who received another local anesthetic block prior to the interscalene block.

• Unable to consent in English