Intercostal cryo-analgesia (ICCA)
Conditions
Interventions
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is time to recovery based on the QoR-15 questionnaire. The QoR-15 questionnaire is developed to evaluate overall health states after surgical and anesthetic procedures across different domains. The total scores range from 0 to 150, with a score of 118 or higher indicating good postoperative recovery. The QoR-15 questionnaire is a valid, reliable patient-reported outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess to what extent ICCA compared to standard postoperative pain management reduces in-hospital pain scores (based on a numeric rating scale (NRS)), postoperative opioid consumption (measured in morphine milligram equivalent (MME)), postoperative complications (i.e., surgery-related complications, surgical site infection, and respiratory tract infections/pneumonia), hospital length of stay, total operative time and first mobilization. To assess whether and to what extent ICCA is superior to our standard postoperative pain management protocol in improving the quality of recovery based on the QoR-15 questionnaire for patients who undergo minimally invasive anatomical lung surgery. The endpoint is measured 1 week, 3 months, and 6 months after surgery. To assess to what extent ICCA compared standard postoperative pain management reduces pain scores (based on NRS), opioid consumption (measured in MME), use of other analgesic medication, and prolonged sensory blockade at home. | — |
Countries
Netherlands
Contacts
Public ContactB.T.G. Köhlen
St. Antonius Ziekenhuis
Outcome results
None listed