Analgesia After Total Shoulder Arthroplasty

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Total Shoulder Arthroplasty

Treatments: Procedure: Interscalene Block (ISB) - 0.1% Ropivacaine + additives; Procedure: Interscalene Block (ISB) - Systemic Control; Procedure: Interscalene Block (ISB) - 0.375% Ropivacaine + additives; Procedure: Interscalene Block (ISB) - 0.2% Ropivacaine + additives

Study type: Interventional

Funder types: Other

Identifiers

NCT01782872

2012-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Interscalene Block (ISB) - 0.375% Ropivacaine + additives

Active Comparator group

Treatment:

Procedure: Interscalene Block (ISB) - 0.375% Ropivacaine + additives

Interscalene Block (ISB) - 0.2% Ropivacaine + additives

Active Comparator group

Treatment:

Procedure: Interscalene Block (ISB) - 0.2% Ropivacaine + additives

Interscalene Block (ISB) - 0.1% Ropivacaine + additives

Active Comparator group

Treatment:

Procedure: Interscalene Block (ISB) - 0.1% Ropivacaine + additives

Interscalene Block (ISB) - Systemic Control

Active Comparator group

Treatment:

Procedure: Interscalene Block (ISB) - Systemic Control