Analgesia After Total Shoulder Arthroplasty

Total Shoulder Arthroplasty Clinical Trial

Official title:

Analgesia After Total Shoulder Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782872
• Other study ID #: 2012-014
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2012
• Last updated: March 20, 2014
• Start date: October 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Shoulder Arthroplasty

Intervention

Procedure:
• Interscalene Block (ISB) - 0.375% Ropivacaine + additives
Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
• Interscalene Block (ISB) - 0.2% Ropivacaine + additives
Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
• Interscalene Block (ISB) - 0.1% Ropivacaine + additives
Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
• Interscalene Block (ISB) - Systemic Control
Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS) Pain Score with Movement	Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)	24 hours after the interscalene block is given	No
Secondary	Duration of Analgesia from Interscalene Nerve Block	Patients will be asked about the duration of analgesia from an analgesic interscalene block at each visit until the block has resolved	Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM	No
Secondary	Numeric Rating Scale (NRS) Pain Scores at Rest and with Movement	Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest and with movement	Day of surgery (preop & 1-2 hours after arrival in the Post Anesthesia Care Unit), postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM	No
Secondary	Middle Deltoid & Hand Grip Strength	A physical assessment will be done to determine the strength of the middle deltoid muscle and hand grip in the operative arm using a dynamometer	Day of surgery (preop & 1-2 hours after arrival in the Post Anesthesia Care Unit), postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM	No