Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
CompletedNot applicableNCT03578237
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chronic" pain. The objective of the proposed pilot study is to optimize the protocol and collect data to power subsequent, definitive clinical trials. Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain. Hypothesis 1a (primary): The severity of surgically-related pain will be significantly decreased on postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1b: The incidence of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Specific Aim 2: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia improves postoperative functioning. Hypothesis 2a: Following primary unilateral knee and shoulder arthroplasty as well as rotator cuff repair, joint range of motion will be significantly increased within the year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 2b: Following video-assisted thoracoscopic surgery, inspiratory spirometry will be improved within the month following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Study details
- Official title
- Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery
- Conditions
- Mastectomy
- Upper Limb Amputation Below Elbow
- Upper Limb Amputation Above Elbow
- Lower Limb Amputation Below Knee
- Lower Limb Amputation Above Knee
- Knee Arthropathy
- Shoulder Arthroplasty
- Rotator Cuff Repair
- Video-Assisted Thoracoscopic Surgery (VATS)
- Skin Grafting
- Interventions
- Device: Cryoneurolysis (active)
- Device: Sham cryoneurolysis procedure
- Sponsor
- University of California, San Diego
- Collaborators
- Epimed International; Pacira Pharmaceuticals, Inc
- Start date
- 2018-08-25
- Primary completion
- 2022-01-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. adult patients of at least 18 years of age 2. scheduled for a primary, unilateral total knee or shoulder arthroplasty, primary unilateral rotator cuff repair, VATS procedure, skin grafting of the lateral thigh, unilateral or bilateral mastectomy, or limb amputation distal to the femoral/humeral head and including at least one metatarsal/metacarpal bone 3. single-injection or continuous peripheral nerve blocks block or epidural infusion planned for perioperative analgesia 4. accepting of a cryoneurolysis procedure Exclusion Criteria: 1. chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks) 2. pregnancy 3. incarceration 4. inability to communicate with the investigators 5. morbid obesity (body mass index \> 40 kg/m2) 6. possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03578237