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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05884099
Other study ID # 2024-11564
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date November 9, 2025

Study information

Verified date January 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Alex Moore, MD
Phone 514-890-8000
Email alex.moore@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 9, 2025
Est. primary completion date May 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Procedure:
Cryoanalgesia AND single-injection paravertebral block
CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
Single-injection paravertebral block
Paravertebral block with Bupivacaine 0.5%

Locations

Country Name City State
Canada Centre Hospitalier de l'Universite de Montreal Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

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