Cryo nerve block for pain after minimally invasive lung surgery
A Randomized Controlled Trial Studying the Effect of Additional Intercostal Cryo-analgesia (ICCA) to Standard Postoperative Pain Management in Patients Undergoing Minimally Invasive Lung Surgery
This study will test whether freezing the intercostal nerves during minimally invasive lung surgery reduces pain and opioid use for adults having VATS or RATS lung resections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 1 site (Nieuwegein, Utrecht) |
| Trial ID | NCT06861387 on ClinicalTrials.gov |
What this trial studies
The study examines intercostal cryo-analgesia (ICCA), a technique that uses controlled cold to temporarily reduce nerve activity, as an addition to multimodal pain management for patients undergoing minimally invasive anatomic lung resections. Participants undergoing VATS or RATS lobectomy, segmentectomy, or pneumonectomy will receive ICCA plus standard multimodal analgesia and outcomes will be compared with those receiving standard multimodal analgesia alone. Primary outcomes include postoperative pain scores, opioid consumption, and measures of recovery and hospital stay. The trial aims to provide higher-quality comparative data than the small observational studies done so far.
Who should consider this trial
Good fit: Adults aged 18 or older who are electively scheduled for minimally invasive anatomical lung resection (VATS or RATS) and can give informed consent are eligible.
Not a fit: Patients on long-term opioids, with liver failure restricting acetaminophen use, connective tissue disease, pregnancy, or other contraindications to ICCA may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, ICCA could reduce postoperative pain and opioid requirements and help patients recover faster after minimally invasive lung resection.
How similar studies have performed: Small observational studies and case series have suggested benefit from ICCA in reducing pain and opioid use, but randomized controlled data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients are at least 18 years or older. 2. Patients are electively scheduled to undergo minimally invasive (i.e., VATS or RATS) anatomical lung (i.e., pneumonectomy, (bi)lobectomy, or segmentectomy) resection for benign or malignant disease. 3. Proficient understanding of the consequences of enrolment by the patients. 4. Written informed consent by the patient. Exclusion Criteria: 1. Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB. 2. Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months). 3. Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol) 4. Patients with connective tissue disease. 5. Patients with comorbidities or history contra-indicating ICCA. 6. Patients who are pregnant. 7. Participation in other clinical trial(s) that may interfere with the current trial.
Where this trial is running
Nieuwegein, Utrecht
- St. Antonius Ziekenhuis — Nieuwegein, Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Bart Köhlen
- Email: b.kohlen@antoniusziekenhuis.nl
- Phone: +31 88 320 1108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.