FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy (NCT07637370)
FROST-STERN: Functional Recovery and Opioid Sparing Technique for STERNotomy A Randomized Trial of Intraoperative Intercostal Cryoablation for Postoperative Pain Management Following Full Sternotomy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (7 items).
Location: Rutgers University Robert Wood Johnson University Hospital — New Brunswick, New Jersey
Age range: 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Rutgers University Robert Wood Johnson University Hospital — New Brunswick, New Jersey
📞 Contact the Study Coordinator
Phone: (732) 235-6155
Email: ricardo.verdiner@rutgers.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Intervention Group: Patients will receive bilateral intraoperative intercostal nerve cryoablation at levels T2-T6 from within the surgical field prior to sternal closure.
Explore by condition: All Pulmonary Dysfunction clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.