Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)

Официальное название

A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty

Обзор

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).

Подробное описание

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 cumulative opioid consumption in the post-operative of 90 days as measured by morphine milligram equivalents (MMEs) compared to those patients who did not receive the intervention prior to a RTSA.

Secondary: Assess the effectiveness of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients to show:

1. a decreased pain score as measured by a Pain Assessment Documentation Tool (PADT) score 2. increased range of motion 3. increased patient reported outcome scores via the American Shoulder and Elbow Surgeons (ASES) shoulder score when compared to those that did not receive any intervention prior to a RTSA?

Вмешательства

• Устройство Cryoneurolysis
  Cryoneurolysis of the suprascapular nerve
• Другое No cryoneurolysis
  Control Group

Первичные конечные точки

• 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). [Срок оценки: 90 days]

Вторичные конечные точки (3)

• Decreased Pain Assessment and Documentation Tool (PADT) scores [Срок оценки: 90 days]
• Improved range of motion (ROM) of the shoulder as measured by the investigators and physical therapy documentation [Срок оценки: 90 days]
• Decreased American Shoulder and Elbow Surgeons (ASES) patient reported outcomes [Срок оценки: 90 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Orthopaedic Specialists of Dallas — Rockwall

Публикации

• MacRae F, Boissonnault E, Hashemi M, Winston P. Bilateral Suprascapular Nerve Cryoneurolysis for Pain Associated With Glenohumeral Osteoarthritis: A Case Report. Arch Rehabil Res Clin Transl. 2023 Jan 25;5(1):100256. doi: 10.1016/j.arrct.2023.100256. eCollection 2023 Mar. PMID 36968166
• Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26. PMID 32858194
• Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60. PMID 16880882

Идентификаторы

NCT: NCT07125833 · IIT 24-376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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