Clinical trial NCT01782872: Analgesia After Total Shoulder Arthroplasty
Official title: Analgesia After Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Shoulder Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale (NRS) Pain Score With Movement
timeFrame: 24 hours after the interscalene block is given
Secondary outcomes:
measure: Duration of Analgesia From Interscalene Nerve Block
timeFrame: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM
measure: Numeric Rating Scale (NRS) Pain Scores at Rest
timeFrame: Preop
measure: Middle Deltoid
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: