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NCT Number: NCT05884099

Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the prevention of chronic thoracic pain after VATS lung resection surgery.

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Key information

Conditions

Cryotherapy Effect Chronic Pain Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Surgery Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H1W0B5, Canada

About this study

VATS lung resection is associated with a high incidence of persistent thoracic pain. To our knowledge, there is no study on the effect of cryoanalgesia on the incidence and severity of chronic thoracic pain 3 months after VATS lung resection.

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. In a recent study by Ilfeld & al, intercostal cryoanalgesia (combined with a single-injection paravertebral block) was able to drastically lower the incidence of chronic pain after total mastectomy compared to the use of the paravertebral block alone (3% vs 17%).

The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia for the prevention of chronic thoracic pain after VATS lung resection surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by VATS for lung cancer
  • American Society of Anesthesiologists (ASA) score 1-3

Exclusion criteria

  • Contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space)
  • Contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia)
  • Epidural analgesia preferred (high risk of thoracotomy, marginal lung function)
  • Surgical criteria (conversion to thoracotomy, non anatomical wedge resection)
  • Preoperative thoracic or shoulder pain on the operated side
  • Known allergy to acetaminophen, celecoxib, sulfa, or both hydromorphone and morphine
  • History of thoracic surgery on the operated site
  • Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine)
  • Inability to understand pain scales or to communicate clearly despite adequate teaching
  • Contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate < 60 mL/min, active gastric ulcer)
  • Pregnancy
  • Patient refusal to participate

Treatment and study plan

Cryoanalgesia AND single-injection paravertebral block

Procedure

CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%

Single-injection paravertebral block

Procedure

Paravertebral block with Bupivacaine 0.5%

Primary outcomes

  1. Incidence of persistent thoracic pain

    Time frame: 3 months

    Persistent postoperative thoracic pain (yes or no)

Secondary outcomes

  1. Incidence of persistent thoracic pain

    Time frame: 1 and 6 months

    Persistent postoperative thoracic pain (yes or no)

  2. Severity of persistent thoracic pain

    Time frame: 1,3 and 6 months

    Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough

  3. Incidence of persistent opioid consumption

    Time frame: 1,3 and 6 months

    Persistent postoperative opioid consumption (yes/no)

  4. Incidence of postoperative neuropathic pain

    Time frame: 48 hours, 1 month and 6 months

    DN4 score (10 points) ; positive if 4 points or more

  5. Incidence of new prescription for neuropathic pain medication

    Time frame: 1, 3 and 6 months

    Yes or no

  6. Persistent hypoesthesia over the ipsilateral thorax

    Time frame: 1 and 6 months

    Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament as well as the subjective presence of a sensation of hypoesthesia.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection

Acronym: CRYO-VATS-2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2023
Registry last updated
Jul 4, 2025

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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