Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

NCT ID: NCT05884099

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2025-04-21

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.

Conditions

Cryotherapy Effect; Chronic Pain; Lung Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cryoanalgesia AND single-injection paravertebral block

Intervention Type: PROCEDURE

CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%

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

Group Type: ACTIVE_COMPARATOR

Single-injection paravertebral block

Intervention Type: PROCEDURE

Paravertebral block with Bupivacaine 0.5%

Interventions

Cryoanalgesia AND single-injection paravertebral block

CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%

Intervention Type: PROCEDURE

Single-injection paravertebral block

Paravertebral block with Bupivacaine 0.5%

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Universite de Montreal

Locations

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 35929983 (View on PubMed)

Other Identifiers

2024-11564

Identifier Type: -

Identifier Source: org_study_id