Clinical trial NCT06861387: Cryo Nerve Block Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intercostal Nerve Block
Cryo Analgesia
Minimally Invasive Lung Surgery
Keywords: cryo analgesia
intercostal nerve block
minimally invasive lung surgery
pain management
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, blinded randomized controlled
Primary purpose: TREATMENT

Brief summary: Background Minimally invasive lung surgery, such as video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS), has become more common for lung resections because it leads to faster recovery, less pain, and shorter hospital stays. However, pain after surgery remains a major issue. Current guidelines suggest using a combination of pain management strategies to reduce the use of opioids and their side effects. Intercostal cryo-analgesia (ICCA), a technique that uses cold to reduce nerve activity, may help lower pain and opioid use after surgery. However, there is limited research on ICCA, with most studies having small sample sizes and lacking randomized controlled trials. More research is needed to compare ICCA with standard pain management in patients having minimally invasive lung surgery.

Objective:

The goal of this study is to determine if ICCA improves recovery compared to the standard pain management after minimally invasive lung surgery. We aim to measure recovery time and quality using the Quality of Recovery 15 (QoR-15) questionnaire. We expect that ICCA will result in better recovery, less pain, less use of opioids, and shorter hospital stays, without increasing the risk of nerve damage or other complications.

Study Design:

This will be a single-center, blinded, randomized controlled trial, along with an observational registry.

Study Population:

The study will include adults who are having elective minimally invasive lung resections.

Intervention:

Patients in the intervention group will receive ICCA in addition to the standard pain management after surgery. ICCA will be administered by the surgeon before closing the wound, targeting the intercostal nerves between ribs 3 and 7.

Main Study Parameters/Endpoints:

The main outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several areas, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool to measure recovery from surgery.

Risks and Benefits:

This trial will examine the effects of adding ICCA to the standard pain management protocol. Potential risks include numbness or nerve damage, neuropathic pain (pain caused by nerve injury), or complications like bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include better recovery, reduced opioid use, less pain, shorter hospital stays, and fewer breathing problems after surgery.


Eligibility 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.

Primary outcomes:
measure: Quality of Recovery
timeFrame: 6 months
Secondary outcomes:
measure: Pain scores
timeFrame: 6 months
measure: Postoperative opioid consumption
timeFrame: 6 months
measure: Concomittant analgesia
timeFrame: 6 months
measure: Postoperative complications
timeFrame: 6 months
measure: Length of stay hospital
timeFrame: 6 months
measure: Operative time
timeFrame: 6 months
Other outcomes:
measure: Presence of neuropathic pain or other sensory changes
timeFrame: 6 months
measure: Prolonged analgesia
timeFrame: 6 months
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
Study officials:
References: