Compairing R-ICNB and C-ICNB for Postoperative Pain Management After Minimal-invasive Anatomical Lung Resection

NCT07099469 | Active Not Recruiting

• 1 other identifier: 004017
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study in which a total of 6 people will participate. This study aims to optimize the postoperative pain management of an anatomically minimally invasive lung resection (RATS) by comparing 2 pain-relieving techniques. As standard, an intercostal block is placed at the end of the procedure by injecting a local anesthetic at the site where the patient will be operated on. This study compares the previous method with the use of cryotherapy as an intercostal block. This technique uses cryo probes and blocks postoperative pain for 1-3 months. By comparing both techniques, it is examined whether cryotherapy requires less pain medication and is therefore more effective.

Conditions

Postoperative Pain Management; RATS Surgery

Keywords

C-ICNB; R-ICNB; RATS Surgery; postoperative pain

Outcome Measures

Primary Outcomes (1)

• The NRS pain score

  The NRS score will be used to measure pain scores and this will be the primary outcome of the study.

  Baseline, post-operative (day 0) in the recoveryward when the patient is awake and after 6 hours. Day 1-2-3 the NRS wil be measured in the morning, afternoon and evening. During the Follow-up visits: 2 weeks and 12 weeks after surgery

Secondary Outcomes (8)

• QoR-15 questionnaire

  Measured at baseline, post-operative after surgery day 0, day 1, day 2 day 3 and day 4 during hospitalisation. At Folluw-up visit after 2 weeks and after 12 weeks

• Lenght of stay

  From date of hospitalization until discharge, estimated time of hospitalisation is 5 days, but we will measure until discharge from the hospital.

• Use of pain medication

  during the postopertieve hospotalization periode, day 0 till day 3

• Pain during mobilization

  During the postopertieve hospotalization periode, day 0 till day 3

• Patient satisfaction

  During post-opertieve periode day 0 - day 3.

Study Arms (2)

R-ICNB

At the end of the procedure, an intercostal block is placed by injecting a local anesthetic into the site of surgery.

C-ICNB

At the end of the surgery single shot cryotherapy will be placed at 6 levels (T3-T8) with the AtriCure"s cryoICE cryosphere cryoablation probes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for anatomical lung resection (lobectomy or segmentectomy) with the intention of performing it by robotic-assisted thoracoscopic surgery (RATS) are eligible for the trial.

You may qualify if:

• Adult patients of 18 years or older who are able to give informed consent and fill out questionnaires in Dutch.

You may not qualify if:

• Patients who need an anatomic resection of the lung that's larger than one lung lobe, who have CPAM or infections.
• Patients with chronic use (\>3 months) of strong opioids because of co-morbidities -for example, the use of tramadol is allowed.
• If there's a high risk of conversion to a thoracotomy. This will be evaluated by the lung surgeon.
• Patients who have had thoracic surgery in the past.
• Patients with chronic kidney disease stage 4 or 5 (GFR \< 30 mL/min)

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2560, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Prof. J. Hendriks, MD. PhD.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. J. Hendriks

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: August 1, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

BE (1)