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NCT Number: NCT06861387

Cryo Nerve Block Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Location status: Recruiting

Location contact

Bart Köhlen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are at least 18 years or older.
  • 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.
  • Proficient understanding of the consequences of enrolment by the patients.
  • Written informed consent by the patient.

Exclusion criteria

  • Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB.
  • Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months).
  • Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol)
  • Patients with connective tissue disease.
  • Patients with comorbidities or history contra-indicating ICCA.
  • Patients who are pregnant.
  • Participation in other clinical trial(s) that may interfere with the current trial.

Treatment and study plan

Cryotherapy

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 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.

PAiN - multimodal analgesia

Drug

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

Primary outcomes

  1. Quality of Recovery

    Time frame: 6 months

    Quality of Recovery based on the Quality of Recovery (QoR-15) questionnaire, whereas a minimum of 118 points correspondents with a clinically good recovery

Secondary outcomes

  1. Pain scores

    Time frame: 6 months

    In-hospital and outpatient pain scores are based on the numeric rating scale (NRS), whereas score 0 means "no pain" and 10 "extreme pain"

  2. Postoperative opioid consumption

    Time frame: 6 months

    In-hospital and outpatient postoperative opioid consumption is measured in MME use.

  3. Concomittant analgesia

    Time frame: 6 months

    use of concomittant analgesia

  4. Postoperative complications

    Time frame: 6 months

    • Surgery-related complications.
    • Surgical site infection.
    • Respiratory tract infections/pneumonia.
    • Pneumothorax.
    • Chest wall hematoma.
  5. Length of stay hospital

    Time frame: 6 months

    Length of stay hospital

  6. Operative time

    Time frame: 6 months

    Total operative time

Other outcomes

  1. Presence of neuropathic pain or other sensory changes

    Time frame: 6 months

    hypesthesia, hyperesthesia and/or allodynia

  2. Prolonged analgesia

    Time frame: 6 months

    Prolonged analgesia more than 3 months after the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Bart Köhlen

CONTACT

[email protected]

+31 88 320 1108

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 6, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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