Cryoanalgesia for Postoperative Pain

Overseen By Nora Ibrahim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Opioids

Disqualifiers: Thorax surgery, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cryoanalgesia, which uses extreme cold to numb nerves and block pain, can effectively manage pain after heart surgery. It has successfully reduced pain and hospital stays for lung surgery patients, and researchers aim to determine its effectiveness for heart surgeries. Participants will receive either this cold treatment or standard pain management. Ideal candidates are those scheduled for specific heart surgeries, such as bypass or valve surgery, and who expect to breathe independently within a day after surgery. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research in pain management following heart surgery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids before the surgery, you would not be eligible to participate.

What prior data suggests that cryoanalgesia is safe for postoperative pain management?

Research has shown that cryoanalgesia, which uses cold to block pain, is generally safe for managing post-surgical pain. Studies have found that patients tolerate this method well, with only minor risks such as infection and bruising, which typically heal on their own. In addition to its safety, cryoanalgesia is linked to reduced need for painkillers, less pain, and shorter hospital stays. These benefits suggest it could be a promising option for individuals undergoing heart surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryoanalgesia for postoperative pain because it offers a unique approach to pain management. Unlike standard treatments like opioids or nerve blocks, cryoanalgesia targets specific intercostal nerves using extreme cold to numb them, potentially reducing the need for medications that can have side effects or lead to dependency. This technique involves applying a cryoprobe directly to nerves, providing pain relief by interrupting pain signal transmission without systemic drug involvement. It's a promising method for delivering effective, localized pain control, which could enhance recovery times and improve patient comfort after surgery.

What evidence suggests that cryoanalgesia is effective for postoperative pain in cardiac surgery?

Research has shown that cryoanalgesia, which participants in this trial may receive, effectively reduces post-surgical pain. Studies have found that it provides better pain relief and reduces the need for opioids compared to methods like nerve blocks. Patients have reported significant pain relief and lower pain levels with cryoanalgesia. Evidence also indicates that cryoanalgesia can reduce both immediate and long-term post-surgical pain. Overall, it appears to be a promising option for managing pain after surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients scheduled for elective heart bypass or single valve surgery who can be taken off a ventilator within 24 hours after the operation. It's not suitable for those using opioids before surgery, pregnant or breastfeeding women, individuals unable to consent, those needing certain post-op support like ECMO, with chronic pain conditions, cold-related disorders, or previous chest surgeries.

Inclusion Criteria

I am expected to breathe without a ventilator within 24 hours after surgery.

I am scheduled for heart bypass or valve surgery through a chest cut.

Exclusion Criteria

I am not pregnant or breastfeeding.

My surgery will be done through a partial breastbone incision.

I am undergoing or have undergone a Cox maze procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoanalgesia during cardiac surgery via median sternotomy

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for pain quality, pain severity, and opioid consumption postoperatively

180 days

Multiple visits (in-person and virtual) at 24 hours, 48 hours, 10 days, 90 days, and 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Cryoanalgesia

Trial Overview The study tests cryoanalgesia—a technique that uses extreme cold to block nerve pain signals—using the cryoICE® system with CryoS probe in cardiac surgery patients. The goal is to see if this method reduces opioid use and hospital stay duration by effectively managing postoperative pain.

How Is the Trial Designed?

Group I: Cryoanalgesia Experimental Treatment 1 Intervention

Intraoperative analgesic administration will be at the discretion of the anesthesia provider. Once adequate hemostasis is achieved and prior to sternal wire placement and chest closure, patients will undergo cryoablation of bilateral T2 - T6 intercostal nerves. The cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. Each cryoablation at -50°C to -70°C will be applied for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6).

Group II: Standard of Care (Control) Active Control 1 Intervention

Patients in this arm will receive standard of care pain management alone.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482123/

Cryoanalgesia - StatPearls - NCBI Bookshelf - NIH Results from multiple studies have shown cryoanalgesia to be a good postoperative pain reduction method, among other benefits.[22] In a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8361293/

Cryoanalgesia for postsurgical pain relief in adults Cryoanalgesia may be associated with better pain relief and opioid reduction than intercostal nerve blocks.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03578237

Cryoanalgesia to Prevent Acute and Chronic Pain ... Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950553425000760

Analgesic outcomes following ultrasound-guided ... Following cryoneurolysis, each patient reported significant pain relief, as was exhibited by a reduction in pain scores, as well as weaning from opioid ...

5. cureus.com cureus.com/articles/337006-cryoneurolysis-a-comprehensive-review-of-applications-in-pain-management

Cryoneurolysis: A Comprehensive Review of Applications ... Reduced pain with significantly less opioid usage along with less time. Additionally, the full range of motor function was observed two to three ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11931670/

Cryoneurolysis: A Comprehensive Review of Applications in ... Cryoneurolysis has a favorable safety profile, presenting a low risk of minor complications such as infection and bruising, which resolve with ...

7. trialx.com trialx.com/clinical-trials/listings/309126/cryoneurolysis-for-acute-postoperative-pain-following-total-knee-arthroplasty/

Cryoneurolysis for Acute Postoperative Pain Following ... A retrospective chart-review of 100 patients undergoing TKA found that cryoneurolysis significantly lowered LOS, reduced opioid consumption ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2049080121006397

Review Cryoanalgesia for postsurgical pain relief in adults Cryoanalgesia with opioids also resulted in less postoperative nausea compared to opioid analgesia alone (relative risk [RR] 0.23, 95 % CI 0.06 to 0.95), but ...