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

Not Applicable

Completed

• Conditions: Osteoarthritis: Shoulder
• Interventions: Procedure: Interscalene brachial plexus block; Procedure: bupivacaine extended-release liposome injection

• Registration Number: NCT02695758
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-24
• Last Update Submitted: 2016-02-24
• Study First Posted: 2016-03-01
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interscalene brachial plexus block	Interscalene brachial plexus block	Direct interscalene nerve block injection via brachial plexus
Bupivacaine extended-release liposome injection	bupivacaine extended-release liposome injection	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.

Primary Outcome Measures

Name	Time	Method
Morphine and Morphine Equivalent consumption	24 hours following surgery