Actively Recruiting
Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
Led by North Texas Medical Research Institute, PLLC · Updated on 2025-08-15
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
North Texas Medical Research Institute, PLLC
Lead Sponsor
P
Pacira Pharmaceuticals, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this research is to find out if a treatment called cryoneurolysis can reduce pain after reverse total shoulder replacement surgery. This treatment uses cold to temporarily block a nerve in the shoulder. The study will compare people who receive the treatment to those who do not, to see if it helps lower pain and reduce the need for opioid pain medications after a reverse total shoulder surgery (RTSA).
CONDITIONS
Official Title
Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients or females who are not pregnant and do not plan to become pregnant during the study
- Age between 30 and 85 years
- Body mass index (BMI) of 45 or less
- Scheduled for elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
- Able to provide informed consent
- Able to communicate and understand English
- Willing to follow all study procedures
You will not qualify if you...
- Poorly controlled medical conditions preventing surgery, such as poorly controlled diabetes (HbA1C > 8.0), kidney problems (eGFR < 60), or severe heart failure (NYHA class 3 or 4)
- Unable to receive cryoneurolysis due to conditions like cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, or wounds near the treatment site
- History of total joint infection or any infection within the last 6 months
- ASA score greater than 3 or Outpatient Arthroplasty Risk Assessment (OARA) score over 80
- Previous cryoneurolysis of the suprascapular nerve or use of supplemental pain control methods like cannabidiol within 30 days before surgery
- Use of significant blood-thinning medications other than aspirin within 7 days before treatment
- Cardiovascular surgery within the last 6 months
- Significant neurological problems affecting the upper limb to be operated on or other neurological conditions that could affect results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Orthopaedic Specialists of Dallas
Rockwall, Texas, United States, 75032
Actively Recruiting
Research Team
J
Jeff Neumann, PA-C
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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