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NCT05144828 | Recruiting | Pain, Postoperative


Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection
Sponsor:

Medical College of Wisconsin

Information provided by (Responsible Party):

Mario Gasparri, MD

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

Condition or disease

Pain, Postoperative

Lung Diseases

Intervention/treatment

Intercostal Nerve Cryoablation

Patient-controlled analgesia (PCA)

Phase

Phase 4

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 : Interventional
Estimated Enrollment : 40 participants
Masking: Single
Primary Purpose: Treatment
Official Title: Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024
Arm Intervention/treatment

Experimental: Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control

Intercostal nerve cryoablation using the CryoICE® CRYOS-L cryoablation probe and an intercostal nerve block of nerves 4-9 performed using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin

Device: Intercostal Nerve Cryoablation

Active Comparator: Standard of Care (SOC) Pain Control

Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin

Drug: Patient-controlled analgesia (PCA)

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection

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Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection

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Locations


Recruiting

United States, Wisconsin

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

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