Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Cryotherapy Effect; Surgery; Chronic Pain
• Interventions: Procedure: Cryoanalgesia AND single-injection paravertebral block; Procedure: Single-injection paravertebral block

• Registration Number: NCT05884099
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

VATS lung resection is associated with a high incidence of persistent thoracic pain. To our knowledge, there is no study on the effect of cryoanalgesia on the incidence and severity of chronic thoracic pain 3 months after VATS lung resection.

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. In a recent study by Ilfeld \& al, intercostal cryoanalgesia (combined with a single-injection paravertebral block) was able to drastically lower the incidence of chronic pain after total mastectomy compared to the use of the paravertebral block alone (3% vs 17%).

The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia for the prevention of chronic thoracic pain after VATS lung resection surgery.

Study Timeline

• Study First Submitted: 2023-05-20
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-01
• Study Start: 2023-11-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-01-21
• Study Completion: 2025-04-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intercostal cryoanalgesia AND single-injection paravertebral block	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.
Single-injection paravertebral block	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

Primary Outcome Measures

Name	Time	Method
Incidence of persistent thoracic pain	3 months	Persistent postoperative thoracic pain (yes or no)

Secondary Outcome Measures

Name	Time	Method
Incidence of persistent opioid consumption	1,3 and 6 months	Persistent postoperative opioid consumption (yes/no)
Incidence of postoperative neuropathic pain	48 hours, 1 month and 6 months	DN4 score (10 points) ; positive if 4 points or more
Incidence of new prescription for neuropathic pain medication	1, 3 and 6 months	Yes or no
Persistent hypoesthesia over the ipsilateral thorax	1 and 6 months	Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament as well as the subjective presence of a sensation of hypoesthesia.
Incidence of persistent thoracic pain	1 and 6 months	Persistent postoperative thoracic pain (yes or no)
Severity of persistent thoracic pain	1,3 and 6 months	Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough

Trial Locations

Locations (1)

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada