Post-operative Pain Clinical Trial
Official title:
Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks: A Randomized, Triple-Masked, Placebo-Controlled Study
Verified date | July 2019 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research study to determine if putting local anesthetic through a tiny tube next to the nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder procedure performed on the frozen shoulder. It will also help determine if patients have a higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their post-procedure pain control.
Status | Terminated |
Enrollment | 4 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Undergoing theraputic manipulation for adhesive capsulitis of the shoulder - age 18 years or older - accepting a single-injection nerve block for manipulation - understanding possible perineural infusion-related complications, study protocol, and catheter/pump care - having caretaker through the first night after manipulation - having an ASA physical status classification of 1-3 Exclusion Criteria: - Any contraindications for a CISB - any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery - known allergy or other contraindication to the study medications - pregnancy - known hepatic or renal insufficiency/disease - peripheral neuropathy of the surgical extremity - morbid obesity - inability to communicate with the investigators and hospital staff - moderate-to-severe shoulder arthritis - immunocompromised status of any etiology - incarceration |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Passive glenohumeral abduction, as evaluated using standard goniometry restricting scapular movement in a supine position. The difference in abduction the day following manipulation compared with the pre-manipulation value, expressed as a percentage. | change from baseline: measured immediately prior to manipulation and the morning following the manipulation. |
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