Cryo Nerve Block Trial

NCT ID: NCT06861387

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-12

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.

Conditions

Intercostal Nerve Block; Cryo Analgesia; Minimally Invasive Lung Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cryo-analgesia

The intervention group will receive intercostal cryo-analgesia and standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: DEVICE

AtriCure's cryoICE cryoSPHERE probe will be inserted through one of the incisions used for VATS/RATS. Cryo-analgesia will be performed unilaterally on the intercostal nerve at the level Th3-Th7. Thus, cryo-analgesia will be applied on 5 intercostal levels. The probe will be placed at the inferior aspect of the ribs, posterior to the mid-axillary line, directly on the neurovascular bundle. One freezing cycle takes approximately 2 minutes and a temperature of between minus 50 and 70 degrees Celsius will be applied.

PAiN - multimodal analgesia

Intervention Type: DRUG

Our standard postoperative pain management plan consists of intercostal nerve block, patient controlled analgesia and acetaminophen

Standard care

The control group will receive standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.

Group Type: ACTIVE_COMPARATOR

PAiN - multimodal analgesia

Intervention Type: DRUG

Our standard postoperative pain management plan consists of intercostal nerve block, patient controlled analgesia and acetaminophen

Registry

The registry group will receive intercostal cryo-analgesia and standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen. Patient are eligible for the registry group in case they refuse randomization

Group Type: OTHER

Cryotherapy

Intervention Type: DEVICE

AtriCure's cryoICE cryoSPHERE probe will be inserted through one of the incisions used for VATS/RATS. Cryo-analgesia will be performed unilaterally on the intercostal nerve at the level Th3-Th7. Thus, cryo-analgesia will be applied on 5 intercostal levels. The probe will be placed at the inferior aspect of the ribs, posterior to the mid-axillary line, directly on the neurovascular bundle. One freezing cycle takes approximately 2 minutes and a temperature of between minus 50 and 70 degrees Celsius will be applied.

PAiN - multimodal analgesia

Intervention Type: DRUG

Our standard postoperative pain management plan consists of intercostal nerve block, patient controlled analgesia and acetaminophen

Interventions

Cryotherapy

AtriCure's cryoICE cryoSPHERE probe will be inserted through one of the incisions used for VATS/RATS. Cryo-analgesia will be performed unilaterally on the intercostal nerve at the level Th3-Th7. Thus, cryo-analgesia will be applied on 5 intercostal levels. The probe will be placed at the inferior aspect of the ribs, posterior to the mid-axillary line, directly on the neurovascular bundle. One freezing cycle takes approximately 2 minutes and a temperature of between minus 50 and 70 degrees Celsius will be applied.

Intervention Type: DEVICE

PAiN - multimodal analgesia

Our standard postoperative pain management plan consists of intercostal nerve block, patient controlled analgesia and acetaminophen

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

B.T.G. Köhlen

Coordinating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

Central Contacts

Bart Köhlen

Role: CONTACT

b.kohlen@antoniusziekenhuis.nl

+31 88 320 1108

Facility Contacts

Bart Köhlen

Role: primary

b.kohlen@antoniusziekenhuis.nl

Other Identifiers

NL88359.100.24

Identifier Type: -

Identifier Source: org_study_id