Knee Arthropathy Clinical Trial
Official title:
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery
Verified date | January 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | November 25, 2022 |
Est. primary completion date | January 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Epimed International, Myoscience (prior to merger with Pacira Pharmaceuticals) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Pain (Mastectomy Subjects Only) | 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 | afternoon of postoperative day 2 | |
Secondary | Analgesic Consumption | Analgesic consumption for previous 24 hours | Postoperative days 1, 2, 3, 4, 7, 14, 21, as well as months 1, 3, 6, and 12 | |
Secondary | Brief Pain Inventory (Interference Subscale) | The Brief Pain Inventory short form (interference scale) is designed to assess pain's impact on physical and emotional functioning. It has established reliability and validity, with minimal inter-rater discordance, and is recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus statement. The interference domaine is comprised of 7 questions involving the degree of pain's interference on physical and emotional functioning using a 0-10 Likert scale (0 = none; 10 = complete). The scale is thus 0-70 with higher scores equivalent to more interference due to pain> | Months 1, 3, 6, and 12 | |
Secondary | Worst Pain Measured on the 11 Point Numeric Rating Scale | The subjects' perception of their worst level pain in the previous 24 hours 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 | Postoperative days 1, 2, 3, 4, 7, 14, and 21 | |
Secondary | Average Pain Measured on the 11 Point Numeric Rating Scale | The subjects' perception of their average level pain in the previous 24 hours 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 | Postoperative days 1, 2, 3, 4, 7, 14, and 21 | |
Secondary | Difficultly Sleeping Due to Pain | Difficulty sleeping due to pain (binary answer: yes or no; not based on a scale or instrument). The numbers presented in the results are the number of participants in each treatment group answering YES, they DID have difficulty sleeping due to pain | Postoperative days 1, 2, 3, 4, 7, 14, and 21 | |
Secondary | Number of Awakenings | Number of awakenings from sleep due to pain (simply the number of times of awakenings--not based on a scale or instrument) | Postoperative days 1, 2, 3, 4, 7, 14, and 21 | |
Secondary | Nausea | Nausea measured on a 0-10 scale with 0=no nausea and 10=vomiting; thus higher on the scale is worse | Postoperative days 1, 2, 3, 4, 7, 14, and 21 | |
Secondary | Phantom Pain Occurences [Mastectomy & Amputation] | How many times in the previous 3 days subject experienced phantom pain (the number of times experienced--not based on a scale or instrument) | Postoperative months 1, 3, 6, and 12 | |
Secondary | Phantom Pain Duration [Mastectomy & Amputation] | The average duration of phantom pain occurrences in the previous 3 days | Postoperative months 1, 3, 6, and 12 | |
Secondary | Phantom Sensation Occurrences [Mastectomy & Amputation] | How many times in the previous 3 days subject experienced phantom sensations (the number of times experienced--not based on a scale or instrument). This outcome differs from "phantom pain occurrences" in that for this outcome no pain is necessary; rather, participants feel the missing body part is actually there, when it is not--yet it is not a painful sensation. | Postoperative months 1, 3, 6, and 12 | |
Secondary | Phantom Sensation Duration [Mastectomy & Amputation] | The average duration of phantom sensation occurrences in the previous 3 days. This outcome differs from "phantom pain duration" in that for this outcome no pain is necessary; rather, participants feel the missing body part is actually there, when it is not--yet it is not a painful sensation. | Postoperative months 1, 3, 6, and 12 | |
Secondary | Residual Limb or Wound Pain Occurences | How many times in the previous 3 days subject experienced residual limb or wound pain (the number of times experienced--not based on a scale or instrument) | Postoperative months 1, 3, 6, and 12 | |
Secondary | Residual Limb or Wound Pain Duration | The average duration of residual limb or wound pain occurrences in the previous 3 days | Postoperative months 1, 3, 6, and 12 |
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