Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection (CRYO-VATS)

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

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery; Cryotherapy Effect; Paravertebral Block; Video-Assisted
• Intervention / Treatment: Procedure: Cryoanalgesia AND single-injection paravertebral block; Procedure: Single-injection paravertebral block

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Moore, MD; Phone Number: 12132 514-890-8000; Email: alex.moore@umontreal.ca
• Study Contact Backup: Name: Evangelos Koliakos, MD; Phone Number: 8444 514-890-8000; Email: evangeloskoliakos@gmail.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X3E4
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal
      • Contact: Alex Moore, MD; Email: alex.moore@umontreal.ca

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intercostal cryoanalgesia AND single-injection paravertebral block; Videothoracoscopic-guided single-injection paravertebral block at T5 with 0.4 mL/kg of Bupivacaine 0.5% with adrenalin 5 mcg/mL (maximum 40 mL) at the beginning of surgery; Cryoanalgesia 5 cm lateral to the neuraxial, on the inferior costal border, CO2 at (-)50C to (-)70C for 2 minutes, repeated on 7 costal levels (T3-T9), after the lung resection and before chest closure.	Procedure: Cryoanalgesia AND single-injection paravertebral block; CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
Active Comparator: Single-injection paravertebral block; -Videothoracoscopic-guided single-injection paravertebral block at T5 with 0.4 mL/kg of Bupivacaine 0.5% with adrenalin 5 mcg/mL (maximum 40 mL) at the beginning of surgery	Procedure: Single-injection paravertebral block; Paravertebral block with Bupivacaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute thoracic pain during cough	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Postoperative morphine-equivalents consumption	Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily	7 days
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
Hypoesthesia over the ipsilateral thorax	Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament	24 hours
Incidence of nausea related to opioid consumption	Evaluation for nausea (yes or no)	7 days
Time to hospital discharge	Total time between the end of surgery and prescription for hospital discharge	30 days
Evaluation of sedation related to opioid consumption	Using the Ramsay score (1 to 6)	7 days
Incidence of vomiting related to opioid consumption	Evaluation for vomiting (yes or no)	7 days
Incidence of pruritus related to opioid consumption	Evaluation for pruritus (yes or no)	7 days

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Alex Moore, MD, Centre Hospitalier de l'Universite de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): November 9, 2024
• Study Completion (Estimated): November 8, 2025

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2024-11561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No