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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. The results of this study may lead to a useful alternative for pain control in cardiac surgery patients.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+