FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy

NCT07637370 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Pro2026000975
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale: Open-heart surgery via a median sternotomy is associated with severe acute postoperative pain. This pain can impair a patient's ability to take deep breaths and cough effectively which increases the risk of postoperative lung complications such as atelectasis (collapsed lung) or pneumonia. Traditional pain management protocols rely heavily on opioid medications, which carry systemic side effects including respiratory depression, sedation, and nausea. While short-acting regional nerve blocks are helpful, their effects often wear off within the first 24 hours. The result is a suboptimal duration of pain relief for the remaining critical early recovery window. Intra-operative intercostal nerve cryoablation (temporary nerve freezing) offers a prolonged, localized, and non-opioid alternative. By temporarily interrupting pain signals along the chest wall, this technique may preserve early respiratory function and reduce systemic narcotic requirements during acute recovery. Study Objective:The objective of this study is to evaluate whether adding bilateral intra-operative intercostal nerve cryoablation (levels T2 through T6) improves the recovery of pulmonary function and reduces acute pain in patients undergoing elective cardiac surgery via a full median sternotomy. Study Design:This is a prospective, randomized, double-blind, sham-controlled, single-center trial. A total of 100 adult patients scheduled for elective first-time cardiac surgery (such as coronary artery bypass grafting or valve replacement) will be randomized in a 1:1 ratio into either an intervention or control group. Intervention Group: Patients will receive bilateral intraoperative intercostal nerve cryoablation at levels T2-T6 from within the surgical field prior to sternal closure. Control Group: Patients will receive standard-of-care multimodal analgesia. Patients, clinical staff managing postoperative care, and data assessors will be fully blinded to the treatment assignment. Primary Outcome:Pulmonary Function Recovery (FEV1 and Incentive Spirometry): Measured as the percentage of the patient's preoperative baseline Forced Expiratory Volume in 1 second (FEV1) and incentive spirometry recovered at 48 hours postoperatively. Key Secondary Outcomes: Cumulative postoperative opioid consumption (measured in Morphine Milligram Equivalents, or MME) during the first 72 hours. Subjective pain intensity scores at rest and during deep inspiration/coughing (using a 0-10 Numerical Rating Scale) at 12, 24, 48, and 72 hours. Key recovery milestones, including time to first extubation, intensive care unit (ICU) length of stay, and total hospital length of stay. Incidence of long-term or chronic post-sternotomy pain syndrome at 3 and 6 months follow-up.

Conditions

Pulmonary Dysfunction; Median Sternotomy Recovery; Postoperative Pain

Keywords

cryoablation; cryoanalgesia; nonopioid analgesia; median sternotomy; intercostal nerve block; cryoneurolysis; cardiac surgery; CABG; cardiac valve replacement; post operative pain; FEV1; enhanced recovery after surgery ERAS; MME; Opioid Sparing Effect; Post surgical neuralgia; chronic post sternotomy pain; allodynia; nerve regeneration

Outcome Measures

Primary Outcomes (2)

• FEV1 Comparison to Baseline

  Percent recovery of Forced Expiratory Volume in one second (FEV1) measured in liters at day of extubation, 48, and 72 hours postoperatively. The final values will be measured as the ratio of the Postoperative extubation day 1, day 2, and day 3 volumes to the preoperative baseline FEV1 results. (e.g. POD3 FEV1 Volume/Baseline FEV1 Volume= Percent Recovery POD 3 FEV1,.... etc)

  After Extubation day 1-3

• Incentive Spirometery Comparison to Baseline

  The percent recovery of volumetric Incentive Spirometry at day of extubation, 48 and 72 hours post operatively. This is calculated as a direct ratio comparing the absolute values (measured in liters) obtained on Postoperative Days (POD) 2 and 3 against the patient's preoperative baseline values (e.g. POD2 IS Volume/IS Baseline Volume=Percent Recovery POD 2 IS). Bedside testing will be facilitated by trained research or respiratory staff using a standard sternal stabilization pillow to mitigate incisional strain.

  After extubation day 1- 3.

Secondary Outcomes (8)

• Recovery Milestones (Extubation)

  This will be documented in terms of hours from end of original surgery.

• Recovery Milestone (Ambulation)

  Hours from end of surgery.

• Pain Intensity

  After extubation day 1-3

• Opioid Consumption

  Postoperatively after extubation day 1-3.

• Chronic Pain

  Postoperatively 3 months after day of surgery

Study Arms (2)

Intercostal Nerve Cryoablation Group

EXPERIMENTAL

Patients in this group receive the active treatment-intraoperative bilateral intercostal nerve cryoablation (levels T2-T6) before the chest is closed.

Device: Intercostal Nerve Cryoablation

Control Group

NO INTERVENTION

Patients in this group receive standard post-operative pain management.

Interventions

Intercostal Nerve Cryoablation DEVICE

This is cryoablation of intercostal nerves after median sternotomy (an opioid sparing technique) to reduce post operative pain past 48hrs.

Also known as: cryoneurolysis

Intercostal Nerve Cryoablation Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Adults aged 40 and above no upper limit.
• Surgical Plan: Undergoing first-time elective cardiac surgery via full median sternotomy (e.g., CABG, AVR, MVR).
• Cognitive Status: Ability to understand and provide informed consent and utilize a Numerical Rating Scale (NRS) for pain.
• Baseline Pain: Preoperative chronic pain score of \< 3/10.

You may not qualify if:

• Redo Sternotomy: Previous cardiac surgery (due to adhesions and altered anatomy).
• Opioid Tolerance: Preoperative daily opioid use for \>4 weeks (to avoid confounded MME requirements).
• Neurological Conditions: Pre-existing intercostal neuralgia, peripheral neuropathy, or significant psychiatric disorders.
• Emergency Cases: Hemodynamically unstable patients or those requiring emergency "crash" surgery.
• Allergies: Known hypersensitivity to local anesthetics (if used in the control arm).
• Anatomical Barriers: Severe chest wall deformities or extensive pleural adhesions.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• AtriCure, Inc.: collaborator

Study Sites (1)

Rutgers University Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Hyperalgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• Ricardo Verdiner, M.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Verdiner, M.D.

CONTACT

732-235-6155; ricardo.verdiner@rutgers.edu

Danielle Plyler

CONTACT

732-2356284; plylerde@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients in the interventional group receive the active treatment-intraoperative bilateral intercostal nerve cryoablation (levels T2-T6) before the chest is closed. Patients in the control group receive standard post-operative pain management.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available beginning 6 months after the primary publication of the trial results and will remain accessible for up to 3 years following publication.
• Access Criteria: Proposals should be directed via email to the Principal Investigator. To gain access, data requestors must submit a formal research protocol detailing the predefined hypotheses and statistical analysis plan. The proposal will be vetted by the trial's steering committee. Approved requestors will be required to sign a standard institutional Data Use Agreement prior to secure data transfer.

Locations

US (1)