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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01782872
Other study ID # 2012-014
Secondary ID
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


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
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Completed NCT03969875 - Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
Completed NCT04364867 - Exparel for Total Shoulder Arthroplasty Phase 4