Liposomal Bupivacaine for Postoperative Pain in Shoulder Surgery

Recruiting in Palo Alto (17 mi)

Overseen byJohnny K Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Johnny K. Lee

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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 130 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).

Eligibility Criteria

This trial is for adults aged 18-90, weighing at least 60 kg, undergoing shoulder replacement surgery. They must understand English to give consent. It's not for those allergic to local anesthetics, pregnant women, patients with severe liver/kidney disease or on dialysis, and those having multiple surgeries in one hospital stay.

Inclusion Criteria

I weigh 60 kg or more.

Must be able to consent in English

I am between 18 and 90 years old.

+1 more

Exclusion Criteria

I need surgery urgently.

I am not allergic to any local anesthetics used in the trial.

I cannot use liposomal bupivacaine due to health reasons.

+8 more

Participant Groups

The study compares pain control and opioid use after shoulder surgery between two groups: one receiving regular bupivacaine and the other getting liposomal bupivacaine mixed with a lower dose of regular bupivacaine plus saline. Participants are randomly assigned to either group without knowing which treatment they receive.

2Treatment groups

Experimental Treatment

Group I: Plain Bupivacaine GroupExperimental Treatment1 Intervention

36 mL (180 mg) 0.5% bupivacaine

Group II: Liposomal Bupivacaine GroupExperimental Treatment1 Intervention

10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Marcaine for: