Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA

Rothman Institute Orthopaedics

Status: Completed

Conditions: Osteoarthritis: Shoulder

Treatments: Procedure: bupivacaine extended-release liposome injection; Procedure: Interscalene brachial plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT02695758

2016Nam2

Details and patient eligibility

About

A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.

Exclusion criteria

1. Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
2. Revision arthroplasty, arthroplasty for fracture
3. Unable/unwilling to consent for enrollment
4. Unable to complete postoperative pain survey
5. Known adverse drug reaction or allergy to the medications used
6. Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
7. Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
8. Patients under the age of 18 years
9. Patients with history of hepatic disease
10. Pregnant women or women who are breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

interscalene brachial plexus block

Active Comparator group

Description:

Direct interscalene nerve block injection via brachial plexus

Treatment:

Procedure: Interscalene brachial plexus block

Bupivacaine extended-release liposome injection

Active Comparator group

Description:

Infiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues.

Treatment:

Procedure: bupivacaine extended-release liposome injection