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Cryoanalgesia for Post-Surgical Chronic Pain in Lung Cancer (CRYO-VATS-2 Trial)

N/A

Recruiting

Led By Alex Moore, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours, 1 month and 6 months

Awards & highlights

CRYO-VATS-2 Trial Summary

This trial tests a technique to give long-term pain relief after lung surgery to prevent chronic pain.

Who is the study for?

This trial is for patients with lung cancer who are fit (ASA score 1-3) and scheduled for VATS lung resection surgery. It's not suitable for those who can't understand pain scales, have certain drug contraindications, pre-existing thoracic or shoulder pain, specific cold-related conditions, coagulopathy issues, a preference for epidural analgesia due to high risk of thoracotomy or poor lung function, previous thoracic surgery on the same side, regular opioid use or pregnancy.Check my eligibility

What is being tested?

The study tests if intercostal cryoanalgesia combined with a single-injection paravertebral block can prevent chronic pain after VATS lung resection better than just the injection alone. Participants will be divided into two groups: one receiving both treatments and the other only the injection.See study design

What are the potential side effects?

Potential side effects may include localized discomfort from cryotherapy such as numbness or skin changes at the site of application. The paravertebral block could cause soreness where injected and less commonly complications like infection or nerve damage.

CRYO-VATS-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific lung surgery for cancer.

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My health is good to moderately impaired according to the ASA score.

CRYO-VATS-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours, 1 month and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours, 1 month and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours, 1 month and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Incidence of new prescription for neuropathic pain medication

Incidence of persistent opioid consumption

Incidence of persistent thoracic pain

+3 more

CRYO-VATS-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intercostal cryoanalgesia AND single-injection paravertebral blockExperimental Treatment1 Intervention

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 II: Single-injection paravertebral blockActive Control1 Intervention

-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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

366 Previous Clinical Trials

129,557 Total Patients Enrolled

2 Trials studying Chronic Pain

703 Patients Enrolled for Chronic Pain

Alex Moore, MDPrincipal InvestigatorCentre Hospitalier de l'Universite de Montreal

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants in this research project?

"Affirmative. Clinicaltrials.gov has evidence that this medical trial, which went live on November 9th 2023, is actively recruiting participants for the study. Approximately 80 subjects are desired from a single site of research."

Answered by AI

Are there any vacancies to participate in the experiment?

"Clinicaltrials.gov reports that this medical trial is still searching for participants, having been initially published on November 9th 2023 and updated most recently on the 10th of November in the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

Alex Moore 2023. "Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05884099.