Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

University of Virginia

Status and phase: Completed; Phase 3

Conditions: Analgesia

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04974385

HSR210190

Details and patient eligibility

About

The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18 years of age or older
• Undergoing total shoulder arthroplasty
• Willing and able to sign consent form to participate in study

Exclusion criteria

• < 18 years of age
• Unwilling or unable to sign consent form to participate in study
• Allergy to local anesthetic
• Medical contraindication to interscalene nerve block
• Chronic opioid use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.

Treatment:

Drug: Liposomal bupivacaine

Drug: Bupivacaine

Non-liposomal Bupivacaine

Active Comparator group

Description:

Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine

Treatment:

Drug: Bupivacaine