What side effects are associated with this type of intervention?

Intercostal cryoanalgesia, used for prolonged pain relief after thoracic surgery, can have side effects such as localized pain at the treatment site, temporary numbness, and potential nerve damage leading to prolonged sensory deficits. Other risks include infection, bleeding, and pneumothorax due to the invasive nature of the procedure.

What prior FDA approvals exist?

Intercostal cryoanalgesia, which involves freezing intercostal nerves to provide prolonged pain relief, is a technique being studied for its efficacy in managing acute thoracic pain post-surgery. While specific FDA approvals for intercostal cryoanalgesia are not detailed, similar pain management strategies for thoracic surgery often involve the use of local anesthetics and nerve blocks. Traditional methods include epidural analgesia and paravertebral blocks, which are commonly used and have FDA-approved medications such as bupivacaine and ropivacaine. These treatments aim to provide effective pain relief and improve postoperative recovery.

What other types of research exist?

Promising alternatives to intercostal cryoanalgesia for thoracic surgery patients include: 1) Single-injection paravertebral blocks, which provide effective pain relief with fewer side effects. 2) Epidural analgesia, which offers continuous pain control and can be tailored to patient needs. 3) Multimodal analgesia, combining different classes of pain medications to enhance pain relief while minimizing side effects. 4) Transcutaneous electrical nerve stimulation (TENS), which is non-invasive and can reduce pain perception. 5) Liposomal bupivacaine, a long-acting local anesthetic that provides extended pain relief when used in nerve blocks.

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Procedure

Cryoanalgesia for Post-VATS Pain (CRYO-VATS 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days

Awards & highlights

CRYO-VATS Trial Summary

This trial aims to show the effectiveness of a cryotherapy technique to provide pain relief after lung surgery.

Who is the study for?

This trial is for patients scheduled for elective lung cancer surgery (like removing a part of the lung) using VATS, with an ASA score indicating they are fit for anesthesia and surgery. It's not suitable for those outside this group.Check my eligibility

What is being tested?

The study tests if adding intercostal cryoanalgesia to a single paravertebral block can better manage pain after VATS lung resection compared to just the block alone.See study design

What are the potential side effects?

Cryoanalgesia may cause localized numbness, skin changes, or nerve damage. The paravertebral block could lead to discomfort at injection site, bleeding, infection, or rarely breathing difficulties.

CRYO-VATS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Acute thoracic pain at rest

Acute thoracic pain during cough

Evaluation of sedation related to opioid consumption

+7 more

CRYO-VATS 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments in thoracic surgery include intercostal cryoanalgesia, paravertebral blocks, and systemic analgesics. Intercostal cryoanalgesia works by freezing the intercostal nerves, leading to prolonged pain relief by causing localized nerve damage that temporarily interrupts pain signal transmission. Paravertebral blocks involve injecting anesthetics near the spinal nerves to block pain in the thoracic region. Systemic analgesics, such as opioids and NSAIDs, work by reducing pain perception and inflammation throughout the body. These treatments are crucial for thoracic surgery patients as they significantly reduce postoperative pain, enhance recovery, and improve overall patient outcomes.

Bronchoscopic cryotherapy for advanced bronchial carcinoma.Cryotherapy for advanced carcinoma of the trachea and bronchi.Treatment of Pulmonary Carcinoid Tumors With Bronchoscopic Cryotherapy: A 28-Year Single-center Experience.

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Who is running the clinical trial?

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

370 Previous Clinical Trials

129,789 Total Patients Enrolled

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

1 Previous Clinical Trials

80 Total Patients Enrolled

~33 spots leftby Nov 2024

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