Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

• Status: Enrolling by invitation
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

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

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• All patients undergoing total shoulder arthroplasty (not a reverse)

• Age ≥ 18 years

• Ability to understand and the willingness to sign an IRB-approved informed consent document.

• ASA patient status I-III patients

• Weight Greater than or equal to 50 kg

Exclusion Criteria:

• Contraindications to an interscalene block or phrenic blockade

• Infection at injection site

• Pre-existing neurological dysfunction affecting the operative extremity

• Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of long-acting opioids

• BMI >40

• Uncontrolled diabetes (A1c >8.0)

• Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery

• Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)

• Patients who are wards of the state

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.

• Patients with moderate-severe hepatic or renal impairment