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Completed

NCT Number: NCT05859061

Cryoanalgesia Study

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
  • Reasonable expectation to be extubated within 24 hours postop

Exclusion criteria

  • Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy)
  • Hemisternotomy approach
  • History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy
  • Preoperative use of opioids
  • History of chronic pain or associated syndromes
  • Concurrent Cox maze procedure
  • Need for post-bypass mechanical circulatory support (ECMO, IABP) or open chest
  • Women who are pregnant or breastfeeding
  • Patients who are unable to consent for themselves

Treatment and study plan

cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe

Device

Per manufacturer instructions, 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. The study team plans to perform each cryoablation (-50°C to -70°C) for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). The probe will be removed after defrosting to avoid mechanical damage to the intercostal nerve. Cryoablation will be performed once hemostasis is achieved and prior to sternal wire placement and chest closure by a provider from the cardiac surgery team.

Other names: Cryoablation

Primary outcomes

  1. Average Daily Opioid Consumption in MME

    Time frame: 48 hours

    The average daily opioid consumption in morphine milligram equivalents (MME) during the first 48 hours postoperatively serves as the study's primary outcome.

Secondary outcomes

  1. Quality of Recovery Score

    Time frame: 48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

    Scale Title: Quality of Recovery Score Scale Values: 0 - 18 Higher score means a better outcome.

  2. Patient Satisfaction with Pain Control Regimen

    Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

    Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.

  3. Pain Quality

    Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

    Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.

  4. Pain Quality

    Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

    Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome.

  5. Pain Severity

    Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

    Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome.

  6. Pain Severity

    Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

    Scale Title: Numeric Pain Rating Scale Scale Values: 0-10 Higher score means a worse outcome.

  7. Average Daily Pain Scores

    Time frame: during the first 48 hours postoperatively (starting upon ICU arrival)

    Scale Title: CPOT (Critical-Care Pain Observation Tool) Scale Values: 0-8 Higher score means a worse outcome.

  8. Average Daily Pain Scores

    Time frame: during the first 48 hours postoperatively (starting upon ICU arrival)

    Scale Title: NRS (Numeric Rating Scale) Scale Values: 0-10 Higher score means a worse outcome.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 15, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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