Total Shoulder Arthroplasty Clinical Trial
Official title:
Interscalene Dynamometer Pilot Study
Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of the interscalene block, patients often experience sensory and motor blockade. The purpose of this study is to determine the effects of the interscalene block on the anterior deltoid muscle and hand grip strength after total shoulder arthroplasty.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled for primary total shoulder arthroplasty - Age 18 to 80 years old - Planned use of general anesthesia via laryngeal mask airway (LMA) and peripheral nerve block - Ability to follow study protocol - Patients with American Society of Anesthesiologists (ASA) physical status of I, II or III Exclusion Criteria: - Patients younger than 18 years old and older than 80 - Patients not intending to receive general anesthesia and peripheral nerve block - Allergy or intolerance to one of the study medications - Patients with an ASA of IV - Hepatic or renal insufficiency - Chronic opioid use (taking opioids for longer than 3 months) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anterior Deltoid Strength | Anterior deltoid strength as measured by a dynamometer twice daily | 2 days postoperatively | No |
Primary | Hand Grip Strength | Hand grip strength as measured by a dynamometer twice daily | 2 days postoperatively | No |
Secondary | Sensory Data | Pin-prick sensation assessed twice daily | 2 days postoperatively | No |
Secondary | Numeric Rating Scale (NRS) Pain Scores | NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed twice daily | 2 days postoperatively | No |
Secondary | Opioid Usage | Opioid Usage (pre-operative, postoperative day [POD] 1, POD2) | 2 days postoperatively | No |
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