Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection

Thoracic Surgery Clinical Trial

— CRYO-VATS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896150
• Other study ID #: 2024-11561
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: November 8, 2025

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Alex Moore, MD
• Phone: 514-890-8000
• Email: alex.moore[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 8, 2025
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Paravertebral Block
• Thoracic Surgery
• Video-Assisted

Intervention

Procedure:
• Cryoanalgesia AND single-injection paravertebral block
CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
• Single-injection paravertebral block
Paravertebral block with Bupivacaine 0.5%

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Universite de Montreal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute thoracic pain during cough	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)	24 hours
Secondary	Acute thoracic pain at rest	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)	1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days
Secondary	Acute thoracic pain during cough	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)	1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days
Secondary	Postoperative morphine-equivalents consumption	Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily	7 days
Secondary	QoR-15 score : 0 (worst) to 150 (best)	QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia	Preoperative and 48 hours postoperative
Secondary	Hypoesthesia over the ipsilateral thorax	Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament	24 hours
Secondary	Incidence of nausea related to opioid consumption	Evaluation for nausea (yes or no)	7 days
Secondary	Time to hospital discharge	Total time between the end of surgery and prescription for hospital discharge	30 days
Secondary	Evaluation of sedation related to opioid consumption	Using the Ramsay score (1 to 6)	7 days
Secondary	Incidence of vomiting related to opioid consumption	Evaluation for vomiting (yes or no)	7 days
Secondary	Incidence of pruritus related to opioid consumption	Evaluation for pruritus (yes or no)	7 days