Interscalene Dynamometer Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Anterior Deltoid Strength
Study Overview
Brief 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.
Detailed Description
Total shoulder arthroplasty can cause severe postoperative pain. Pain management includes general anesthesia with interscalene block during surgery and intravenous (IV) hydromorphone patient controlled analgesia (PCA) and oral opioid analgesics given after surgery. Side effects, such as motor blockade, may impair participation in physical therapy and diminish patient satisfaction. In order to prepare for a future study that will examine what mixtures of adjuncts/additives will best prevent recovery room pain and minimize motor blockade, the investigators are conducting this pilot study to collect preliminary data on current practice. The investigators believe the current regimen will provide adequate pain relief, but may cause extensive motor blockade and reduce patients' muscle strength after surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Anterior Deltoid Strength
Time Frame: 2 days postoperatively
Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
Hand Grip Strength
Time Frame: 2 days postoperatively
Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
Secondary Outcomes
- Number of Participants With Reduced Sensation in a Dermatome(2 days postoperatively)
- Numeric Rating Scale (NRS) Pain Scores With Movement(2 days postoperatively)
- Total Oral Opioid Intake in 48hrs(0-48hrs)