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Trial Title:
Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection
NCT ID:
NCT05884099
Condition:
Cryotherapy Effect
Chronic Pain
Lung Cancer
Surgery
Conditions: Official terms:
Lung Neoplasms
Chronic Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control
group : single-injection paravertebral block
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Quadruple
Intervention:
Intervention type:
Procedure
Intervention name:
Cryoanalgesia AND single-injection paravertebral block
Description:
CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
Arm group label:
Intercostal cryoanalgesia AND single-injection paravertebral block
Intervention type:
Procedure
Intervention name:
Single-injection paravertebral block
Description:
Paravertebral block with Bupivacaine 0.5%
Arm group label:
Single-injection paravertebral block
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 surgery.
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.
Criteria for 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)
- Preoperative thoracic or shoulder pain on the operated side
- Known allergy to acetaminophen, celecoxib, sulfa, or both hydromorphone and morphine
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier de l'Universite de Montreal
Address:
City:
Montreal
Zip:
H1W0B5
Country:
Canada
Start date:
November 9, 2023
Completion date:
April 21, 2025
Lead sponsor:
Agency:
Centre hospitalier de l'Université de Montréal (CHUM)
Agency class:
Other
Source:
Centre hospitalier de l'Université de Montréal (CHUM)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884099
