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NCT07637370

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

Not Yet Recruiting
NAAges 40+InterventionalTreatment
Rutgers, The State University of New Jersey
~100 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Intercostal Nerve Cryoablation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
FEV1 Comparison to Baseline
Measured over After Extubation day 1-3
+1 more outcome measured

Conditions

Pulmonary Dysfunction
Median Sternotomy Recovery
Postoperative Pain

Explore related trials

Cardiac SurgeryPost-Operative Pain

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Ricardo Verdiner, M.D. · PRINCIPAL_INVESTIGATOR · Rutgers University

Who to contact

Ricardo Verdiner, M.D.
[email protected]
732-235-6155
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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • FEV1 Comparison to BaselineAfter Extubation day 1-3

    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)

  • Incentive Spirometery Comparison to BaselineAfter extubation day 1- 3.

    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.