Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 99
- Locations
- 2
- Primary Endpoint
- Average Pain (Mastectomy Subjects Only)
Study Overview
Brief Summary
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.
Detailed Description
Subjects will be individuals undergoing unilateral or bilateral mastectomy; upper or lower limb amputation; primary, unilateral total knee or shoulder arthroplasty; primary, unilateral rotator cuff repair; video-assisted thoracoscopic surgery; and burn-related skin grafting of the lateral thigh. Those who consent to participate in this study will have standard preoperative peripheral nerve blocks administered and catheters inserted: paravertebral blocks or a fascial plane block (e.g., erector spinae plane block) for mastectomy, femoral/sciatic for lower limb amputation, and brachial plexus (or terminal nerves) for upper limb amputation; femoral or adductor canal for total knee arthroplasty; interscalene for shoulder arthroplasty or rotator cuff repair; thoracic epidural for video-assisted thoracoscopic surgery (VATS); and lateral femoral cutaneous nerve for skin grafting of the lateral thigh.
Treatment group assignment (randomization). Subjects with successfully-administered peripheral nerve blocks (defined by sensory changes in the appropriate nerve distribution) will be allocated to one of two possible treatments:
- cryoneurolysis
- sham cryoneurolysis (placebo control)
Randomization will be stratified by surgery type (e.g., mastectomy, upper limb amputation, and lower limb amputation). Computer-generated randomization lists will be used to create sealed, opaque randomization envelopes with the treatment group assignment enclosed in each envelope labeled with the randomization number.
The specific nerves targeted will depend on the surgical site: intercostal nervesblocks (4 levels depending on the specific surgical approach) for mastectomy; femoral/sciatic for lower limb amputation, and brachial plexus (or terminal nerves) for upper limb amputation; infrapatellar branch of the saphenous nerve for knee arthroplasty; suprascapular nerve for shoulder surgery; intercostal nerves for VATS procedures, and the lateral femoral cutaneous nerve for skin grafting of the lateral thigh. The cryoneurolysis sites will be cleansed with chlorhexidine gluconate and isopropyl alcohol. Using the optimal ultrasound transducer for the specific anatomic location and subject anatomy (linear vs curvilinear array), the target nerves will be identified in a transverse cross-sectional (short axis) view.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Only the investigator/physician applying the cryoneurolysis will be aware of the treatment group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients of at least 18 years of age
- •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
- •single-injection or continuous peripheral nerve blocks block or epidural infusion planned for perioperative analgesia
- •accepting of a cryoneurolysis procedure
Exclusion Criteria
- •chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- •incarceration
- •inability to communicate with the investigators
- •morbid obesity (body mass index > 40 kg/m2)
- •possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
Outcomes
Primary Outcomes
Average Pain (Mastectomy Subjects Only)
Time Frame: afternoon of postoperative day 2
Measured with the 0-10 numeric rating scale as part of the Brief Pain Inventory, with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Secondary Outcomes
- Phantom Pain Occurences [Mastectomy & Amputation](Postoperative months 1, 3, 6, and 12)
- Number of Awakenings(Postoperative days 1, 2, 3, 4, 7, 14, and 21)
- Difficultly Sleeping Due to Pain(Postoperative days 1, 2, 3, 4, 7, 14, and 21)
- Analgesic Consumption(Postoperative days 1, 2, 3, 4, 7, 14, 21, as well as months 1, 3, 6, and 12)
- Worst Pain Measured on the 11 Point Numeric Rating Scale(Postoperative days 1, 2, 3, 4, 7, 14, and 21)
- Average Pain Measured on the 11 Point Numeric Rating Scale(Postoperative days 1, 2, 3, 4, 7, 14, and 21)
- Brief Pain Inventory (Interference Subscale)(Months 1, 3, 6, and 12)
- Phantom Pain Duration [Mastectomy & Amputation](Postoperative months 1, 3, 6, and 12)
- Nausea(Postoperative days 1, 2, 3, 4, 7, 14, and 21)
- Phantom Sensation Occurrences [Mastectomy & Amputation](Postoperative months 1, 3, 6, and 12)
- Phantom Sensation Duration [Mastectomy & Amputation](Postoperative months 1, 3, 6, and 12)
- Residual Limb or Wound Pain Occurences(Postoperative months 1, 3, 6, and 12)
- Residual Limb or Wound Pain Duration(Postoperative months 1, 3, 6, and 12)
Investigators
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego