A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
North Texas Medical Research Institute, PLLC
Summary
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).
Description
Randomized controlled, pilot clinical trial to assess the administration of and feasibility for cyroneurolysis of the suprascapular nerve in the pre-operative setting for patients that will receive a reverse total shoulder arthroplasty (RTSA). Our primary research hypothesis is that patients who receive the intervention treatment of cryoneurolysis will experience decreased opioid usage compared to the control patient population. Primary: Assess the effectiveness and feasibility of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients in reduction of the cumulati…
Eligibility
- Age range
- 30–85 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceCryoneurolysis
Cryoneurolysis of the suprascapular nerve
- OtherNo cryoneurolysis
Control Group
Location
- Orthopaedic Specialists of DallasRockwall, Texas