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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis: Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interscalene brachial plexus block

Direct interscalene nerve block injection via brachial plexus

Group Type ACTIVE_COMPARATOR

Interscalene brachial plexus block

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

bupivacaine extended-release liposome injection

Intervention Type PROCEDURE

Interventions

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Interscalene brachial plexus block

Intervention Type PROCEDURE

bupivacaine extended-release liposome injection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No