Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

NCT05884099 | Completed

• 1 other identifier: 2024-11564
• 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 prevention of chronic thoracic pain after VATS lung resection surgery.

Conditions

Cryotherapy Effect; Chronic Pain; Lung Cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of persistent thoracic pain

  Persistent postoperative thoracic pain (yes or no)

  3 months

Secondary Outcomes (6)

• Incidence of persistent thoracic pain

  1 and 6 months

• Severity of persistent thoracic pain

  1,3 and 6 months

• Incidence of persistent opioid consumption

  1,3 and 6 months

• Incidence of postoperative neuropathic pain

  48 hours, 1 month and 6 months

• Incidence of new prescription for neuropathic pain medication

  1, 3 and 6 months

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)
• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H1W0B5, Canada

Location

Related Publications (1)

• Ilfeld BM, Finneran JJ, Swisher MW, Said ET, Gabriel RA, Sztain JF, Khatibi B, Armani A, Trescot A, Donohue MC, Schaar A, Wallace AM. Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study. Anesthesiology. 2022 Nov 1;137(5):529-542. doi: 10.1097/ALN.0000000000004334.

  PMID: 35929983 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Lung Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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 20, 2023
• First Posted: June 1, 2023
• Study Start: November 9, 2023
• Primary Completion: January 21, 2025
• Study Completion: April 21, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)