Cryoanalgesia Study

June 13, 2025 updated by: Sawyer Naze, Northwestern University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoanalgesia
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).
Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
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
No Intervention: Standard of Care (Control)
Patients in this arm will receive standard of care pain management alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
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.
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
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.
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
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.
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
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.
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
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.
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
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.
during the first 48 hours postoperatively (starting upon ICU arrival)
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.
during the first 48 hours postoperatively (starting upon ICU arrival)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

February 13, 2025

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00218457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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