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

NCT03578237 | Completed Results FDA Device

• 1 other identifier: Cryo Prevention PILOTs
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Analgesic Consumption

  Postoperative days 1, 2, 3, 4, 7, 14, 21, as well as months 1, 3, 6, and 12

• Brief Pain Inventory (Interference Subscale)

  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

• Difficultly Sleeping Due to Pain

  Postoperative days 1, 2, 3, 4, 7, 14, and 21

Study Arms (2)

Treatment (active cryoneurolysis)

EXPERIMENTAL

Receiving active cryoneurolysis

Device: Cryoneurolysis (active)

Sham

SHAM COMPARATOR

Receiving sham cryoneurolysis procedure

Device: Sham cryoneurolysis procedure

Interventions

Cryoneurolysis (active) DEVICE

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

Treatment (active cryoneurolysis)

Sham cryoneurolysis procedure DEVICE

Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe. 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

Also known as: Placebo treatment

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• pregnancy
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Epimed International: collaborator
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

Results Point of Contact

• Title: Program Manager
• Organization: University of California San Diego

baabdullah@health.ucsd.edu

(858) 220-5714

Study Officials

• Brian Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

• John Finneran, MD

  University California San Diego

  STUDY DIRECTOR

• Matthew Swisher, MD, MS

  University California San Diego

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only the investigator/physician applying the cryoneurolysis will be aware of the treatment group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: August 25, 2018
• Primary Completion: January 7, 2022
• Study Completion: November 25, 2022
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)