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.
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.
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.
Parallel
Intercostal Nerve Cryoablation
DeviceThis is cryoablation of intercostal nerves after median sternotomy (an opioid sparing technique) to reduce post operative pain past 48hrs.
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)
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.
Recovery Milestones (Extubation)
Granular tracking of time to first extubation (measured in hours from surgery end).
Recovery Milestone (Ambulation)
Time to first independent ambulation (hours) from end of surgery.
Pain Intensity
Visual Analog Scale (VAS) during incentive spirometry at day of extubation, day 2 and day 3 (POD 2 and 3). Visual Analog Scale (VAS) pain scores (0 to 10 integer scale, where 0 = no pain and 10 = worst imaginable pain) captured dynamically during the performance of incentive spirometry at the day of extubation, day 2 and day 3.
Opioid Consumption
Cumulative systemic narcotic use recorded every 24 hours up to 72 hours, mathematically converted into total Morphine Milligram Equivalents (MME).
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Rutgers, The State University of New Jersey
Lead sponsor
AtriCure, Inc.
Collaborator
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