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NCT02695758 Clinical Trial

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

Osteoarthritis: Shoulder Clinical Trial

Official title:
Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02695758
Other study ID # 2016Nam2
Secondary ID
Status Completed
Phase N/A
First received February 22, 2016
Last updated February 24, 2016
Start date December 2014

Study information
Verified date February 2016
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Interscalene brachial plexus block

• bupivacaine extended-release liposome injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Outcome
Type Measure Description Time frame Safety issue
Primary Morphine and Morphine Equivalent consumption 24 hours following surgery