Analgesia After Total Shoulder Arthroplasty
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
May 18, 2016
CompletedMay 18, 2016
April 1, 2016
1.3 years
September 24, 2012
February 11, 2016
April 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Duration of Analgesia From Interscalene Nerve Block
Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM
Numeric Rating Scale (NRS) Pain Scores at Rest
Preop
Middle Deltoid
24 hours after surgery
Study Arms (4)
Interscalene Block (ISB) - 0.375% Ropivacaine + additives
ACTIVE COMPARATORInterscalene Block (ISB) - 0.2% Ropivacaine + additives
ACTIVE COMPARATORInterscalene Block (ISB) - 0.1% Ropivacaine + additives
ACTIVE COMPARATORInterscalene Block (ISB) - Systemic Control
ACTIVE COMPARATORInterventions
Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jacques YaDeau
- Organization
- Hospital for Special Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques T YaDeau, MD, PhD
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2012
First Posted
February 4, 2013
Study Start
October 1, 2012
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
May 18, 2016
Results First Posted
May 18, 2016
Record last verified: 2016-04