N/A
N=10
Interscalene Dynamometer Pilot Study
Total Shoulder Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01550952 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Anterior Deltoid Strength — 77 percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Deltoid Strength |
77 | — |
| PRIMARY Hand Grip Strength |
90 | — |
| SECONDARY Number of Participants With Reduced Sensation in a Dermatome |
8 | — |
| SECONDARY Numeric Rating Scale (NRS) Pain Scores With Movement |
0.8 | — |
| SECONDARY Total Oral Opioid Intake in 48hrs |
52.3 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01550952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.