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Analgesia After Total Shoulder Arthroplasty

Phase 4
Completed
Conditions
Total Shoulder Arthroplasty
Interventions
Procedure: Interscalene Block (ISB) - 0.2% Ropivacaine + additives
Procedure: Interscalene Block (ISB) - Systemic Control
Procedure: Interscalene Block (ISB) - 0.375% Ropivacaine + additives
Procedure: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Interscalene Block (ISB) - 0.2% Ropivacaine + additivesInterscalene Block (ISB) - 0.2% Ropivacaine + additives-
Interscalene Block (ISB) - Systemic ControlInterscalene Block (ISB) - Systemic Control-
Interscalene Block (ISB) - 0.375% Ropivacaine + additivesInterscalene Block (ISB) - 0.375% Ropivacaine + additives-
Interscalene Block (ISB) - 0.1% Ropivacaine + additivesInterscalene Block (ISB) - 0.1% Ropivacaine + additives-
Primary Outcome Measures
NameTimeMethod
Numeric Rating Scale (NRS) Pain Score With Movement24 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
NameTimeMethod
Duration of Analgesia From Interscalene Nerve BlockPostoperative 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 RestPreop

Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest

Middle Deltoid24 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

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