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Trial record 17 of 45 for:    atricure

Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection

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ClinicalTrials.gov Identifier: NCT05144828
Recruitment Status : Not yet recruiting
First Posted : December 3, 2021
Last Update Posted : December 3, 2021
Sponsor:
Collaborator:
AtriCure, Inc.
Information provided by (Responsible Party):
Mario Gasparri, MD, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE November 22, 2021
First Posted Date  ICMJE December 3, 2021
Last Update Posted Date December 3, 2021
Estimated Study Start Date  ICMJE January 2022
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2021)
  • Visual Analogue Scale Pain Score [ Time Frame: 14 Days post-operatively ]
    Subjective to scale to measure acute and chronic pain
  • Pain medication use [ Time Frame: 21 Days post-operatively ]
    mg of postoperative pain medication taken
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2021)
  • M.D. Anderson Symptom Inventory Score [ Time Frame: Post-operative day 1, week 1, week 2, week 3, week 4, week 5, week 6 ]
    Assessment of symptom severity and interference with everyday life
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANNS) [ Time Frame: Post-operative month 1, month 3, month 6 ]
    Assessment tool to analyze and classify pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection
Official Title  ICMJE Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection
Brief Summary This is a single center, single surgeon, prospective, randomized trial examining the addition of Cryo Nerve Block during robot assisted thoracoscopic anatomic lung resection surgery
Detailed Description

Thoracic surgical procedures are consistently reported to be among the most painful surgical incisions currently used. Trauma to the skin, muscle, intercostal nerves, bones and pleura all contribute and lead to activation of various pain pathways including somatic, visceral, neurogenic and phrenic. In the short term, this pain leads to ineffective cough and pulmonary hygiene resulting in respiratory complications and prolonged hospital stays while in the longer term it leads to prolonged recovery, delayed return to work and in some instances, chronic post thoracotomy pain syndromes. Minimally invasive approaches such as standard thoracoscopy or robotic assisted thoracoscopy have certainly decreased some of this trauma as evidenced by decreased length of stays and decreased complication rates however even with these minimally invasive techniques, recovery to 80% of baseline is 25 days and 9.4% of patients are still using narcotics after 90-180 days.

Several options are available in the management of pain following thoracic surgery with a multimodal pain medicine approach being most common. Opioids, unfortunately, are a relatively large part of this approach and are often relied upon despite their relatively unfavorable adverse event profile and risk for addiction. Many of the other pain adjuncts often used with thoracotomies such as epidural catheters or intraoperatively placed pain catheters are not really reasonable when using minimally invasive approaches as the hospital length of stay is 1-2 days. Intercostal cryoanalgesia has been shown to be a safe and effective strategy for postoperative pain management in patients undergoing thoracotomy. Recent studies have demonstrated the beneficial effect of cryoanalgesia for post-thoracotomy pain in reduction of opioid requirement, reduction in post-operative pain scores, and superior pulmonary function (higher FEV1 and FVC values)5 and that it can produce temporary neurolysis for up to two months without long-term histological nerve damage. To date it has not been studied when using minimally invasive techniques whether it be standard thoracoscopy or robotic assisted thoracoscopy but it would stand to reason that it would be equally or maybe more effective in this patient population and truly maximize the benefits of a minimally invasive approach.

We therefore propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe provides superior post-operative analgesia as compared to our current standard pain management strategy in patients undergoing robotic assisted thoracoscopic anatomic lung resection and allows for decreased opioid use and more rapid recovery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Lung Diseases
Intervention  ICMJE
  • Device: Intercostal Nerve Cryoablation
    Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.
    Other Name: CryoICE CRYO2 croyablation probes (Atricure, Inc.)
  • Drug: Patient-controlled analgesia (PCA)
    Patients will have access to the standard PCA (patient-controlled analgesia) offered at Froedtert Hospital. This includes tylenol 650 mg oral, robaxin 500 mg oral, and tramadol 25-50 mg oral.
Study Arms  ICMJE
  • Experimental: Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control
    Intercostal nerve cryoablation using the CryoICE® CRYO2 cryoablation probe plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin
    Interventions:
    • Device: Intercostal Nerve Cryoablation
    • Drug: Patient-controlled analgesia (PCA)
  • Active Comparator: Standard of Care (SOC) Pain Control
    Prescribed post-operative pain medication, including tramadol, tylenol, and robaxin
    Intervention: Drug: Patient-controlled analgesia (PCA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-85 years of age
  • Acceptable surgical candidate
  • Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

  • Patients undergoing or requiring conversion to thoracotomy
  • Patients with chronic pain syndromes
  • Patients with a history of substance abuse
  • Patients currently using opioids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelly Potzner 414-955-1848 kpotzner@mcw.edu
Contact: Krissa Packard, MS 414-955-1861 kpackard@mcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05144828
Other Study ID Numbers  ICMJE PRO40665
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Gasparri, MD, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE AtriCure, Inc.
Investigators  ICMJE
Principal Investigator: Maria Gasparri, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP