Clinical trial NCT05144828: Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection
Official title: Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lung Diseases
Keywords: Atricure
CryoNB
cryoanalgesia
Medical College of Wisconsin
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2021-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 requiring treatment within the last year
* Patients with a history of illicit drug use
* Patients with a history of heavy alcohol use in the last five years as determined by the principal investigator
* Patients currently using opioids

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS) Pain Score
timeFrame: 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180
measure: Pain medication use
timeFrame: 21 Days post-operatively
Secondary outcomes:
measure: M.D. Anderson Symptom Inventory (MDASI) Score
timeFrame: Post-operative day 1, week 1, week 2, week 3, week 4, week 5, week 6
measure: Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
timeFrame: Post-operative month 1, month 3, month 6
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mario Gasparri, MD
role: PRINCIPAL_INVESTIGATOR
References: