Cryo Nerve Block Trial

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

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 undergoing minimally invasive lung surgery.

Objective:

The goal of this study is to determine whether ICCA improves recovery compared to standard pain management after minimally invasive lung surgery. The investigators aim to measure recovery time and quality using the Quality of Recovery-15 (QoR-15) questionnaire. The investigators expect that ICCA will result in better recovery, less pain, reduced opioid use, 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 undergoing elective minimally invasive lung resections.

Intervention:

Patients in the intervention group will receive ICCA in addition to 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 primary outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several domains, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool for measuring postoperative recovery.

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 such as bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include improved recovery, reduced opioid use, less pain, shorter hospital stays, and fewer respiratory complications after surgery.

Study Overview

• Status: Recruiting
• Conditions: Intercostal Nerve Block; Cryo Analgesia; Minimally Invasive Lung Surgery
• Intervention / Treatment: Device: Cryotherapy; Drug: PAiN - multimodal analgesia

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bart Köhlen; Phone Number: +31 88 320 1108; Email: b.kohlen@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands
      • Recruiting
      • St. Antonius ziekenhuis
      • Contact: Bart Köhlen; Email: b.kohlen@antoniusziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; The control group will receive standard postoperative pain management including intercostal nerve block, patient conrolled analgesia, and acetaminophen.	Drug: PAiN - multimodal analgesia; Our standard postoperative pain management plan consists of intercostal nerve block, patient-controlled analgesia and acetaminophen
Experimental: Cryo-analgesia; The intervention group will receive intercostal cryo-analgesia in addition to standard postoperative pain management, including intercostal nerve block, patient-controlled analgesia, and acetaminophen.	Device: 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 nerves at levels T3-T7. Thus, cryo-analgesia will be applied at five 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 between -50°C and -70°C will be applied.; Drug: PAiN - multimodal analgesia; Our standard postoperative pain management plan consists of intercostal nerve block, patient-controlled analgesia and acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery	Quality of Recovery based on the Quality of Recovery (QoR-15) questionnaire, whereas a minimum of 118 points correspondents with a clinically good recovery	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	In-hospital and outpatient pain scores are based on the numeric rating scale (NRS), whereas score 0 means "no pain" and 10 "extreme pain"	6 months
Postoperative opioid consumption	In-hospital and outpatient postoperative opioid consumption is measured in MME use.	6 months
Concomittant analgesia	use of concomittant analgesia	6 months
Postoperative complications	Surgery-related complications.; Surgical site infection.; Respiratory tract infections/pneumonia.; Pneumothorax.; Chest wall hematoma.	6 months
Length of stay hospital	Length of stay hospital	6 months
Operative time	Total operative time	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of neuropathic pain or other sensory changes	hypesthesia, hyperesthesia and/or allodynia	6 months
Prolonged analgesia	Prolonged analgesia more than 3 months after the surgery	6 months

Collaborators and Investigators

• Sponsor: St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 12, 2029

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain management; intercostal nerve block; cryo analgesia; minimally invasive lung surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Therapeutics; Cryotherapy
• Other Study ID Numbers: NL88359.100.24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No