Interscalene Dynamometer Pilot Study
1 other identifier
observational
10
1 country
1
Brief Summary
Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of the interscalene block, patients often experience sensory and motor blockade. The purpose of this study is to determine the effects of the interscalene block on the anterior deltoid muscle and hand grip strength after total shoulder arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2011
Shorter than P25 for all trials
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
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedResults Posted
Study results publicly available
March 31, 2016
CompletedMarch 31, 2016
September 1, 2012
2 months
March 1, 2012
January 29, 2016
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Anterior Deltoid Strength
Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
2 days postoperatively
Hand Grip Strength
Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
2 days postoperatively
Secondary Outcomes (3)
Number of Participants With Reduced Sensation in a Dermatome
2 days postoperatively
Numeric Rating Scale (NRS) Pain Scores With Movement
2 days postoperatively
Total Oral Opioid Intake in 48hrs
0-48hrs
Eligibility Criteria
Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.
You may qualify if:
- Patients scheduled for primary total shoulder arthroplasty
- Age 18 to 80 years old
- Planned use of general anesthesia via laryngeal mask airway (LMA) and peripheral nerve block
- Ability to follow study protocol
- Patients with American Society of Anesthesiologists (ASA) physical status of I, II or III
You may not qualify if:
- Patients younger than 18 years old and older than 80
- Patients not intending to receive general anesthesia and peripheral nerve block
- Allergy or intolerance to one of the study medications
- Patients with an ASA of IV
- Hepatic or renal insufficiency
- Chronic opioid use (taking opioids for longer than 3 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2012
First Posted
March 12, 2012
Study Start
December 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 31, 2016
Results First Posted
March 31, 2016
Record last verified: 2012-09