Cryotherapy EffectCRYO-VATS-2NCT05884099

Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

A study testing Cryoanalgesia AND single-injection paravertebral block and Single-injection paravertebral block in people with Cryotherapy Effect and Chronic Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cryotherapy Effect, Chronic Pain, Lung Cancer
What is being tested?: Cryoanalgesia AND single-injection paravertebral block and Single-injection paravertebral block
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteCanada
Study dates: 9 Nov 2023to 21 Apr 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H1W0B5

Other trials in Canada

About this study

Official title: Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection

Read the 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
Being tested: Cryoanalgesia AND single-injection paravertebral block, Single-injection paravertebral block
Medical subject headings: Chronic Pain, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cryoanalgesia AND single-injection paravertebral blockProcedure or surgery
CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
Single-injection paravertebral blockProcedure or surgery
Paravertebral block with Bupivacaine 0.5%

Study groups in NCT05884099
Study group	Role	What they receive
Intercostal cryoanalgesia AND single-injection paravertebral block	Experimental	* 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. Receives: Procedure: Cryoanalgesia AND single-injection paravertebral block
Single-injection paravertebral block	Active comparator	-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 Receives: Procedure: Single-injection paravertebral block

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of persistent thoracic pain
Persistent postoperative thoracic pain (yes or no)
Measured: 3 months

Secondary outcomes (6)

Incidence of persistent thoracic pain
Persistent postoperative thoracic pain (yes or no)
Measured: 1 and 6 months
Severity of persistent thoracic pain
Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough
Measured: 1,3 and 6 months
Incidence of persistent opioid consumption
Persistent postoperative opioid consumption (yes/no)
Measured: 1,3 and 6 months
Incidence of postoperative neuropathic pain
DN4 score (10 points) ; positive if 4 points or more
Measured: 48 hours, 1 month and 6 months
Incidence of new prescription for neuropathic pain medication
Yes or no
Measured: 1, 3 and 6 months
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.
Measured: 1 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 202321 Apr 2025

First posted1 Jun 2023
Study start9 Nov 2023
Primary completion21 Jan 2025
Study completion21 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05884099
Sponsor's protocol ID: 2024-11564
Acronym: CRYO-VATS-2
Status last verified: Jul 2025
First submitted: 20 May 2023
Last updated: 4 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35929983

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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All Cryotherapy Effect trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
ClinicalTrials.gov ID: NCT05884099
Acronym / sponsor ID: CRYO-VATS-2 / 2024-11564
Conditions: Cryotherapy Effect, Chronic Pain, Lung Cancer, Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
Study start: 9 Nov 2023 (actual)
Primary completion: 21 Jan 2025 (actual)
Study completion: 21 Apr 2025 (actual)
First posted: 1 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block

Arm	Type	Receives
Intercostal cryoanalgesia AND single-injection paravertebral block	Experimental	Procedure: 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	Active comparator	Procedure: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cryoanalgesia AND single-injection paravertebral blockCO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%	Procedure or surgery	Intercostal cryoanalgesia AND single-injection paravertebral block
Single-injection paravertebral blockParavertebral block with Bupivacaine 0.5%	Procedure or surgery	Single-injection paravertebral block

Primary outcome

Incidence of persistent thoracic pain
Time frame: 3 months
Persistent postoperative thoracic pain (yes or no)

6 secondary outcomes

Incidence of persistent thoracic pain
Time frame: 1 and 6 months
Severity of persistent thoracic pain
Time frame: 1,3 and 6 months
Incidence of persistent opioid consumption
Time frame: 1,3 and 6 months
Incidence of postoperative neuropathic pain
Time frame: 48 hours, 1 month and 6 months
Incidence of new prescription for neuropathic pain medication
Time frame: 1, 3 and 6 months
Persistent hypoesthesia over the ipsilateral thorax
Time frame: 1 and 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
Background: PubMed 35929983Ilfeld 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.
Individual participant dataSharing planned: No

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Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
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Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alex Moore, MD principal investigator

Centre Hospitalier de l'Universite de Montreal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of persistent thoracic pain (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05884099, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.