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Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578237
Recruitment Status : Enrolling by invitation
First Posted : July 6, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Epimed International
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

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.


Condition or disease Intervention/treatment Phase
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 Device: Cryoneurolysis (active) Device: Sham cryoneurolysis procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Only the investigator/physician applying the cryoneurolysis will be aware of the treatment group assignment.
Primary Purpose: Prevention
Official Title: Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery
Actual Study Start Date : July 14, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Receiving active cryoneurolysis
Device: Cryoneurolysis (active)
Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle. Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature

Sham Comparator: Sham
Receiving sham cryoneurolysis procedure
Device: Sham cryoneurolysis procedure
Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle. Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
Other Name: Placebo treatment




Primary Outcome Measures :
  1. Average pain (mastectomy subjects only) [ Time Frame: afternoon of postoperative day 2 ]
    Measured with the NRS as part of the Brief Pain Ineventory


Secondary Outcome Measures :
  1. Analgesic consumption [ Time Frame: Postoperative days 0, 1, 2, 3, 4, 7, 14, 21, as well as months 1, 3, 6, and 12 ]
    Analgesic consumption for previous 24 hours

  2. Brief Pain Inventory [ Time Frame: Months 1, 3, 6, and 12 ]
    The Brief Pain Inventory SF is designed to assess pain and its 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 Brief Pain Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average", "least", and "current" pain levels using a 0-10 Numeric Rating Scale; (2) percentage of relief provided by pain treatments with one question (reported score is the percentage divided by 10 and then subtracted from 10: 0 = complete relief, 10 = no relief); and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale (0 = none; 10 = complete).

  3. Average pain measured on the 11 point NRS [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 14, and 21 ]
    The subjects' perception of their average level pain in the previous 24 hours

  4. Worst pain measured on the 11 point NRS [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 14, and 21 ]
    The subjects' perception of their maximum level pain in the previous 24 hours

  5. Sleeping quality [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 14, and 21 ]
    Difficulty sleeping due to pain? (binary answer: yes or no; not based on a scale or instrument)

  6. Sleeping disturbances [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 14, and 21 ]
    Number of awakenings from sleep due to pain (simply the # of times of awakenings--not based on a scale or instrument)

  7. Nausea [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 14, and 21 ]
    Nausea measured on a 0-10 scale with 0=no nausea and 10=vomiting

  8. Phantom pain incidence [mastectomy & amputation] [ Time Frame: Postoperative months 1, 3, 6, and 12 ]
    How many times in the previous 3 days subject experienced phantom pain (the number of times experienced--not based on a scale or instrument)

  9. Phantom sensation incidence [mastectomy & amputation] [ Time Frame: Postoperative months 1, 3, 6, and 12 ]
    How many times in the previous 3 days subject experienced phantom sensations (the number of times experienced--not based on a scale or instrument)

  10. Residual limb or wound pain incidence [ Time Frame: Postoperative months 1, 3, 6, and 12 ]
    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)

  11. Phantom pain duration [mastectomy & amputation] [ Time Frame: Postoperative months 1, 3, 6, and 12 ]
    The average duration of phantom pain occurrences in the previous 3 days

  12. Phantom sensation incidence [mastectomy & amputation] [ Time Frame: Postoperative months 1, 3, 6, and 12 ]
    The average duration of phantom sensation occurrences in the previous 3 days

  13. Residual limb or wound pain duration [ Time Frame: Postoperative months 1, 3, 6, and 12 ]
    The average duration of residual limb or wound pain occurrences in the previous 3 days

  14. Joint Range of Motion [shoulder and knee arthroplasty and rotator cuff repair] [ Time Frame: Various time points within the first postoperative year (based on clinic visits) ]
    range of motion measured with a standard goniometer

  15. Forced expiratory volume in 1 second (FEV1) [ Time Frame: Various time points within the first month ]
    volume of air exhaled as fast as possible in one second as measured with a standard inspiratory spirometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578237


Locations
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United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Epimed International
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
Investigators
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Principal Investigator: Brian Ilfeld, MD, MS University California San Diego
Study Director: John Finneran, MD University California San Diego
Study Director: Matthew Swisher, MD, MS University California San Diego

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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03578237    
Other Study ID Numbers: Cryo Prevention PILOTs
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Joint Diseases
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Diseases