NCT05144828

Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection

Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Lung Diseases

Interventions

Type	Name	Description
DEVICE	Intercostal Nerve Cryoablation	Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYOS-L 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.
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. All patients will have the first two ports placed at which time an intercostal nerve block of nerves 4-9 will be performed using 0.5% Marcaine with Epinephrine.

Timeline

• Start date: 2022-02-15
• Primary completion: 2024-10-04
• Completion: 2024-12-31
• First posted: 2021-12-03
• Last updated: 2026-04-15
• Results posted: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study