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Completed

NCT Number: NCT05896150

Intercostal Cryoanalgesia for Acute 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 management of acute thoracic pain after VATS lung resection 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

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X3E4, Canada

About this study

VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications.

Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery.

Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection.

The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute 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)
  • Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine
  • Preoperative thoracic or shoulder pain on the operated side
  • 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. Acute thoracic pain during cough

    Time frame: 24 hours

    Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)

Secondary outcomes

  1. Acute thoracic pain at rest

    Time frame: 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days

    Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)

  2. Acute thoracic pain during cough

    Time frame: 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days

    Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)

  3. Postoperative morphine-equivalents consumption

    Time frame: 7 days

    Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily

  4. QoR-15 score : 0 (worst) to 150 (best)

    Time frame: Preoperative and 48 hours postoperative

    QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia

  5. Hypoesthesia over the ipsilateral thorax

    Time frame: 24 hours

    Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament

  6. Incidence of nausea related to opioid consumption

    Time frame: 7 days

    Evaluation for nausea (yes or no)

  7. Time to hospital discharge

    Time frame: 30 days

    Total time between the end of surgery and prescription for hospital discharge

  8. Evaluation of sedation related to opioid consumption

    Time frame: 7 days

    Using the Ramsay score (1 to 6)

  9. Incidence of vomiting related to opioid consumption

    Time frame: 7 days

    Evaluation for vomiting (yes or no)

  10. Incidence of pruritus related to opioid consumption

    Time frame: 7 days

    Evaluation for pruritus (yes or no)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Intercostal Cryoanalgesia for Management of Acute Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection

Acronym: CRYO-VATS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 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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