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NCT07637370 · ClinicalTrials.gov registry record · NA
FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy
A NA study, sponsored by Rutgers, The State University of New Jersey.
- Not yet
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT07637370 is a NA study that has not yet begun recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 100 participants.
The verdict
NCT07637370, a NA study, has not yet begun recruiting, sponsored by Rutgers, The State University of New Jersey.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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 assignm
Interventions
- DEVICE Intercostal Nerve Cryoablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07637370
The ClinicalTrials.gov registry entry for NCT07637370 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intercostal Nerve Cryoablation is the first listed.
NCT07637370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07637370 about?
NCT07637370 is a clinical study titled "FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy". 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 lun...
What is the current status of trial NCT07637370?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2026-07-15. Estimated completion is 2028-08.
What interventions are being tested in trial NCT07637370?
The interventions under investigation include: Intercostal Nerve Cryoablation (DEVICE).
Who is sponsoring clinical trial NCT07637370?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
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