Thoracic SurgeryCRYO-VATSNCT05896150
Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection
A study testing Cryoanalgesia AND single-injection paravertebral block and Single-injection paravertebral block in people with Thoracic Surgery and Video-Assisted, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 management of acute thoracic pain after VATS lung resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Video-Assisted, Cryotherapy Effect
- 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 28 Oct 2024
- 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)
- Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine
- Preoperative thoracic or shoulder pain on the operated side
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, H2X3E4
About this study
Official title: Intercostal Cryoanalgesia for Management of Acute Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
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 management of acute thoracic pain after VATS lung resection surgery.
Read the detailed description
VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications.
Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery.
Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection.
The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.
- Being tested
- Cryoanalgesia AND single-injection paravertebral block, Single-injection paravertebral block
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 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.
Acute thoracic pain during cough
Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
Measured: 24 hours
Secondary outcomes (10)
Acute thoracic pain at rest
Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
Measured: 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days
Acute thoracic pain during cough
Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
Measured: 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days
Postoperative morphine-equivalents consumption
Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily
Measured: 7 days
QoR-15 score : 0 (worst) to 150 (best)
QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia
Measured: Preoperative and 48 hours postoperative
Hypoesthesia over the ipsilateral thorax
Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament
Measured: 24 hours
Incidence of nausea related to opioid consumption
Evaluation for nausea (yes or no)
Measured: 7 days
Time to hospital discharge
Total time between the end of surgery and prescription for hospital discharge
Measured: 30 days
Evaluation of sedation related to opioid consumption
Using the Ramsay score (1 to 6)
Measured: 7 days
Incidence of vomiting related to opioid consumption
Evaluation for vomiting (yes or no)
Measured: 7 days
Incidence of pruritus related to opioid consumption
Evaluation for pruritus (yes or no)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start9 Nov 2023
- Primary completion22 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Moore, MD, Principal investigator, Centre Hospitalier de l'Universite de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896150
- Sponsor's protocol ID
- 2024-11561
- Acronym
- CRYO-VATS
- Status last verified
- Jul 2025
- First submitted
- 19 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
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 Management of Acute Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
- ClinicalTrials.gov ID
- NCT05896150
- Acronym / sponsor ID
- CRYO-VATS / 2024-11561
- 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
- 22 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 9 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.
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 management of acute thoracic pain after VATS lung resection surgery.
Detailed description
VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications.
Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery.
Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection.
The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute 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)
- Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine
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
Acute thoracic pain during cough
Time frame: 24 hours
Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst)
10 secondary outcomes
Acute thoracic pain at rest
Time frame: 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days
Acute thoracic pain during cough
Time frame: 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days
Postoperative morphine-equivalents consumption
Time frame: 7 days
QoR-15 score : 0 (worst) to 150 (best)
Time frame: Preoperative and 48 hours postoperative
Hypoesthesia over the ipsilateral thorax
Time frame: 24 hours
Incidence of nausea related to opioid consumption
Time frame: 7 days
Time to hospital discharge
Time frame: 30 days
Evaluation of sedation related to opioid consumption
Time frame: 7 days
Incidence of vomiting related to opioid consumption
Time frame: 7 days
Incidence of pruritus related to opioid consumption
Time frame: 7 days
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.
- Individual participant dataSharing planned: No
Related trials for Thoracic Surgery
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
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?
A study testing Cryoanalgesia AND single-injection paravertebral block and Single-injection paravertebral block in people with Thoracic Surgery and Video-Assisted, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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?
Acute thoracic pain during cough (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.