Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection

NCT05896150 | Completed

• 1 other identifier: 2024-11561
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Acute thoracic pain during cough

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

  24 hours

Secondary Outcomes (10)

• Acute thoracic pain at rest

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

• Acute thoracic pain during cough

  1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days

• Postoperative morphine-equivalents consumption

  7 days

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

  Preoperative and 48 hours postoperative

• Hypoesthesia over the ipsilateral thorax

  24 hours

Study Arms (2)

Intercostal cryoanalgesia AND single-injection paravertebral block

EXPERIMENTAL

* 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

Single-injection paravertebral block

ACTIVE COMPARATOR

-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

Interventions

Cryoanalgesia AND single-injection paravertebral block PROCEDURE

CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%

Intercostal cryoanalgesia AND single-injection paravertebral block

Single-injection paravertebral block PROCEDURE

Paravertebral block with Bupivacaine 0.5%

Single-injection paravertebral block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X3E4, Canada

Location

Study Officials

• Alex Moore, MD

  Centre Hospitalier de l'Universite de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 9, 2023
• Study Start: November 9, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 28, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)