Completed

NCT Number: NCT02695758

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

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.

Completed

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Key information

Conditions

Osteoarthritis: Shoulder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Interscalene brachial plexus block

Procedure

bupivacaine extended-release liposome injection

Procedure

Primary outcomes

Morphine and Morphine Equivalent consumption

Time frame: 24 hours following surgery

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
First posted: Mar 1, 2016
Registry last updated: Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.