Liposomal Bupivacaine vs Dexamethasone ISB

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Shoulder Pain

Treatments: Drug: Exparel 133 MG Per 10 ML Injection; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04047446

2019-0424

Details and patient eligibility

About

In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I-III
• Age 18 years or older
• Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion criteria

• History of allergy to local anesthetic, or one of the study medications
• Pre-existing neurological deficits
• Psychiatric or cognitive disorders that prohibit patients from following study protocol
• History of drug or alcohol abuse
• Chronic opioid use (longer than 3 months)
• Chronic pain syndromes
• Infection at the site of injection
• Patients with severe pulmonary disease
• Herniated cervical disc, cervical myelopathy
• Contraindication for general anesthesia and/or interscalene nerve block
• Pregnancy
• Open shoulder arthrotomies.
• Non English speakers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Liposomal bupivacaine & standard bupivacaine

Experimental group

Treatment:

Drug: Exparel 133 MG Per 10 ML Injection

Standard bupivacaine & dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone