Clinical trial NCT05896150: Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection
Official title: Intercostal Cryoanalgesia for Management of Acute Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Video-Assisted
Cryotherapy Effect
Paravertebral Block
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute thoracic pain during cough
timeFrame: 24 hours
Secondary outcomes:
measure: Acute thoracic pain at rest
timeFrame: 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days
measure: Acute thoracic pain during cough
timeFrame: 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days
measure: Postoperative morphine-equivalents consumption
timeFrame: 7 days
measure: QoR-15 score : 0 (worst) to 150 (best)
timeFrame: Preoperative and 48 hours postoperative
measure: Hypoesthesia over the ipsilateral thorax
timeFrame: 24 hours
measure: Incidence of nausea related to opioid consumption
timeFrame: 7 days
measure: Time to hospital discharge
timeFrame: 30 days
measure: Evaluation of sedation related to opioid consumption
timeFrame: 7 days
measure: Incidence of vomiting related to opioid consumption
timeFrame: 7 days
measure: Incidence of pruritus related to opioid consumption
timeFrame: 7 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Universite de Montreal
name: Alex Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: