NCT07125833 · North Texas Medical Research Institute, PLLC
Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
What this study 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.
View original scientific description
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).
Interventions
DEVICE
Cryoneurolysis
Cryoneurolysis of the suprascapular nerve
OTHER
No cryoneurolysis
Control Group
Primary outcome measures
The primary endpoint for the primary objective would be decreased opioid utilization in the post-operative period after a reverse total shoulder arthroplasty (RTSA) as measured by Morphine Milligram Equivalents (MME).
Time frame: 90 days
Pain medication usage as recorded by MME. MME is calculated by multiplying the opioid dose (in mg) by a drug-specific conversion factor (e.g., oxycodone × 1.5, hydromorphone × 4, fentanyl patch mcg/hr × 2.4). In research and clinical practice, MME helps quantify total opioid burden, assess risk for overdose, and standardize analgesic reporting in clinical trials. Higher daily MMEs are associated with increased adverse event risk. This will be recorded at every clinical visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation
- between 30-85 years of age
- BMI less than or equal to 45
- Currently setup for an elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
- Ability to provide informed consent to participate in the clinical trial
- Ability to understand and communicate in English
- Willingness to comply with all study procedures
Exclusion criteria
- poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C \> 8.0) renal insufficiency (eGFR \<60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
- inability to receive the intervention including contraindications:
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and open and/or infected wounds at or near the treatment site
- patients with history of total joint infection ever or any infection in the last 6 months
- ASA score \>3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score \> 80.
- previous cryoneurolysis of the suprascapular nerve-utilization of supplemental/holistic methods specifically for pain control (e.g. cannabidiol). This will be discontinued 30 days prior to RTSA and will not be used during the duration of study participation. This will be evaluated by the Principal Investigator and study team prior to consent.
- significant anti-coagulation usage (other than aspirin) 7 days prior to treatment
- CV surgery within the last 6 months
- significant neurologic compromise (acquired or congenital/genetic) of the upper extremity to be operated on or underlying neurologic condition that would confound results in the opinion of the investigator such as a
Where
- Rockwall, Texas
Collaborators
Pacira Pharmaceuticals, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 15, 2025 · Source of record for eligibility and locations