Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05896150
Other study ID # 2024-11561
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date November 8, 2025

Study information

Verified date December 2023
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 management of acute thoracic pain after VATS lung resection surgery.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 8, 2025
Est. primary completion date November 9, 2024
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) - Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine - Preoperative thoracic or shoulder pain on the operated side - 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 Montréal Quebec

Sponsors (1)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute thoracic pain during cough Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) 24 hours
Secondary Acute thoracic pain at rest Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days
Secondary Acute thoracic pain during cough Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days
Secondary Postoperative morphine-equivalents consumption Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily 7 days
Secondary QoR-15 score : 0 (worst) to 150 (best) QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia Preoperative and 48 hours postoperative
Secondary Hypoesthesia over the ipsilateral thorax Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament 24 hours
Secondary Incidence of nausea related to opioid consumption Evaluation for nausea (yes or no) 7 days
Secondary Time to hospital discharge Total time between the end of surgery and prescription for hospital discharge 30 days
Secondary Evaluation of sedation related to opioid consumption Using the Ramsay score (1 to 6) 7 days
Secondary Incidence of vomiting related to opioid consumption Evaluation for vomiting (yes or no) 7 days
Secondary Incidence of pruritus related to opioid consumption Evaluation for pruritus (yes or no) 7 days
See also
  Status Clinical Trial Phase
Recruiting NCT04865874 - GDT-PPV Protocol in Thoracic Surgery N/A
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT02919267 - Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms N/A
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Terminated NCT01320475 - Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine Phase 4
Recruiting NCT05045196 - Health-promoting Family Conversations and Open Heart Surgery N/A
Completed NCT04507958 - Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment
Recruiting NCT05060302 - Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery N/A
Completed NCT05667467 - The Effect of Care Bundle in Heart Surgery N/A
Not yet recruiting NCT03275428 - THRIVE and Non-intubated Thoracic Surgery N/A
Not yet recruiting NCT05482230 - Application of Tracheal Intubation in Lateral Position in Thoracic Surgery N/A
Enrolling by invitation NCT04429009 - A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry N/A
Not yet recruiting NCT03628040 - Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery Phase 3
Recruiting NCT03300622 - Assessment in Patients After Thoracic Surgery N/A
Completed NCT00981474 - Cerebral Autoregulation Monitoring During Cardiac Surgery N/A
Completed NCT03309280 - Influence of Different Parameters on Extubation Time After Cardiac Surgery.
Recruiting NCT03820700 - Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery. N/A
Completed NCT03768193 - Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery N/A
Recruiting NCT04609228 - Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors