Analgesia After Total Shoulder Arthroplasty
- Conditions
- Total Shoulder Arthroplasty
- Interventions
- Procedure: Interscalene Block (ISB) - 0.2% Ropivacaine + additivesProcedure: Interscalene Block (ISB) - Systemic ControlProcedure: Interscalene Block (ISB) - 0.375% Ropivacaine + additivesProcedure: Interscalene Block (ISB) - 0.1% Ropivacaine + additives
- Registration Number
- NCT01782872
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief Summary
The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic \[numbing medicine\] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.
- Detailed Description
All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve block with long-lasting local anesthetic. The three study groups will receive additives (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may reduce postoperative pain. One of the study groups uses the usual concentration of local anesthetic, while the other two study groups use reduced concentrations of local anesthetic. Follow-up with study patients begins on the day of surgery and continues through postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed for sensory function and strength of their shoulder muscle and hand grip.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Patients with osteoarthritis
- Primary total shoulder arthroplasty
- Age 18 to 80 years old
- Planned use of general anesthesia
- Planned use of a brachial plexus nerve block for postoperative analgesia
- Ability to follow study protocol
- Patients younger than 18 years old and older than 80
- Allergy or intolerance to one of the study medications
- Patients with an American Society of Anesthesiologists (ASA) physical status of IV
- Patients with insulin-dependent diabetes
- Patients with hepatic (liver) failure
- Patients with chronic renal (kidney) failure
- Bradycardia (heart rate < 50) or hypotension (systolic blood pressure < 90 mmHg)
- Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome [CRPS]/reflex sympathetic dystrophy [RSD])
- Lack of English fluency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interscalene Block (ISB) - 0.2% Ropivacaine + additives Interscalene Block (ISB) - 0.2% Ropivacaine + additives - Interscalene Block (ISB) - Systemic Control Interscalene Block (ISB) - Systemic Control - Interscalene Block (ISB) - 0.375% Ropivacaine + additives Interscalene Block (ISB) - 0.375% Ropivacaine + additives - Interscalene Block (ISB) - 0.1% Ropivacaine + additives Interscalene Block (ISB) - 0.1% Ropivacaine + additives -
- Primary Outcome Measures
Name Time Method Numeric Rating Scale (NRS) Pain Score With Movement 24 hours after the interscalene block is given Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)
- Secondary Outcome Measures
Name Time Method Duration of Analgesia From Interscalene Nerve Block Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM Median time until a patient needed to take opioid pain medication
Numeric Rating Scale (NRS) Pain Scores at Rest Preop Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest
Middle Deltoid 24 hours after surgery A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States