Actively Recruiting
Effect of Additional Intercostal Cryo-analgesia to Standard Pain Management in Minimally Invasive Lung Surgery Patients: A Randomized Controlled Trial
Led by St. Antonius Hospital · Updated on 2026-04-27
150
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults undergoing minimally invasive lung surgery to see if adding intercostal cryo-analgesia (ICCA) to standard pain management improves recovery. This study compares ICCA, which uses cold to reduce nerve activity between ribs 3 and 7, with the usual pain control methods. The goal is to measure recovery quality and time, focusing on pain, opioid use, hospital stay length, and potential side effects like nerve damage. Participants will be randomly assigned to one of two groups. One group receives ICCA plus standard postoperative pain management, which includes intercostal nerve block, patient-controlled analgesia, and acetaminophen. The other group receives only the standard pain management. ICCA involves applying a cold probe during surgery to nerves at five intercostal levels. This is a single-center, blinded trial with an observational registry. During the study, recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire at six months to evaluate overall recovery. Researchers will also monitor pain scores, opioid use, additional pain medication, complications, hospital stay length, and surgery duration. Participants will be followed for up to six months to track these outcomes and any side effects. The study aims to balance improved recovery with safety risks like numbness or lung complications.
CONDITIONS
Brief Title
Cryo Nerve Block Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Electively scheduled for minimally invasive anatomical lung resection (pneumonectomy, (bi)lobectomy, or segmentectomy) for benign or malignant disease
- Able to understand the consequences of enrollment
- Provided written informed consent
You will not qualify if you...
- Allergy or intolerance to anesthetic drugs used for intercostal nerve block
- Chronic opioid use unrelated to surgery for more than 3 months
- Liver failure preventing use of acetaminophen
- Connective tissue disease
- Comorbidities or history contraindicating intercostal cryo-analgesia
- Pregnancy
- Participation in other clinical trials that may interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to hospital discharge
Participants undergo minimally invasive lung surgery with or without additional intercostal cryo-analgesia and receive standard postoperative pain management including intercostal nerve block, patient-controlled analgesia, and acetaminophen.
1 surgical visit and daily hospital care visits
Duration - 6 months
Participants are followed for recovery, pain management, opioid consumption, and complications after surgery.
Periodic visits over 6 months
Trial Site Locations
Total: 1 location
1
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Actively Recruiting
Research Team
B
Bart Köhlen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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