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Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection (CRYO-VATS-2)

Primary Purpose

Cryotherapy Effect, Chronic Pain, Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cryoanalgesia AND single-injection paravertebral block
Single-injection paravertebral block
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryotherapy Effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intercostal cryoanalgesia AND single-injection paravertebral block

    Single-injection paravertebral block

    Arm Description

    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.

    -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

    Outcomes

    Primary Outcome Measures

    Incidence of persistent thoracic pain
    Persistent postoperative thoracic pain (yes or no)

    Secondary Outcome Measures

    Incidence of persistent thoracic pain
    Persistent postoperative thoracic pain (yes or no)
    Severity of persistent thoracic pain
    Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough
    Incidence of persistent opioid consumption
    Persistent postoperative opioid consumption (yes/no)
    Incidence of postoperative neuropathic pain
    DN4 score (10 points) ; positive if 4 points or more
    Incidence of new prescription for neuropathic pain medication
    Yes or no
    Persistent hypoesthesia over the ipsilateral thorax
    Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament

    Full Information

    First Posted
    May 20, 2023
    Last Updated
    May 30, 2023
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05884099
    Brief Title
    Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection
    Acronym
    CRYO-VATS-2
    Official Title
    Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cryotherapy Effect, Chronic Pain, Lung Cancer, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Quadruple
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intercostal cryoanalgesia AND single-injection paravertebral block
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Single-injection paravertebral block
    Arm Type
    Active Comparator
    Arm Description
    -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
    Intervention Type
    Procedure
    Intervention Name(s)
    Cryoanalgesia AND single-injection paravertebral block
    Intervention Description
    CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
    Intervention Type
    Procedure
    Intervention Name(s)
    Single-injection paravertebral block
    Intervention Description
    Paravertebral block with Bupivacaine 0.5%
    Primary Outcome Measure Information:
    Title
    Incidence of persistent thoracic pain
    Description
    Persistent postoperative thoracic pain (yes or no)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Incidence of persistent thoracic pain
    Description
    Persistent postoperative thoracic pain (yes or no)
    Time Frame
    1 and 6 months
    Title
    Severity of persistent thoracic pain
    Description
    Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough
    Time Frame
    1,3 and 6 months
    Title
    Incidence of persistent opioid consumption
    Description
    Persistent postoperative opioid consumption (yes/no)
    Time Frame
    1,3 and 6 months
    Title
    Incidence of postoperative neuropathic pain
    Description
    DN4 score (10 points) ; positive if 4 points or more
    Time Frame
    48 hours, 1 month and 6 months
    Title
    Incidence of new prescription for neuropathic pain medication
    Description
    Yes or no
    Time Frame
    1, 3 and 6 months
    Title
    Persistent hypoesthesia over the ipsilateral thorax
    Description
    Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament
    Time Frame
    1 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alex Moore, MD
    Phone
    514-890-8000
    Ext
    12132
    Email
    alex.moore@umontreal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Evangelos Koliakos, MD
    Phone
    514-890-8000
    Ext
    8444
    Email
    evangeloskoliakos@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alex Moore, MD
    Organizational Affiliation
    Centre Hospitalier de l'Universite de Montreal
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35929983
    Citation
    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.
    Results Reference
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    Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

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