Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection

NCT05144828 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: PRO40665
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative; Lung Diseases

Keywords

Atricure; CryoNB; cryoanalgesia; Medical College of Wisconsin

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analogue Scale (VAS) Pain Score

  The visual analogue scale is a pain assessment tool intended to help patient care providers assess pain according to individual patient needs. A 0-10 scale is used for patient self-assessment with 0 meaning no pain and 10 meaning worst possible pain.

  14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180

• Pain Medication Use

  Patients will be asked about their pain medication use daily for 21 days following surgery. Total mg of postoperative pain medication taken will be collected.

  21 Days post-operatively

Secondary Outcomes (2)

• M.D. Anderson Symptom Inventory (MDASI) Score

  Screening, Day 1, Day 7, Day 14, Day 21, Day 30, Day 35, Day 42

• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score

  Screening, Day 30, Day 60, Day 180

Study Arms (2)

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

EXPERIMENTAL

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; Drug: Patient-controlled analgesia (PCA)

Standard of Care (SOC) Pain Control

ACTIVE COMPARATOR

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)

Interventions

Patient-controlled analgesia (PCA) DRUG

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.

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

Intercostal Nerve Cryoablation DEVICE

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.

Also known as: CryoICE CRYOS-L cryoablation probes (Atricure, Inc.)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• AtriCure, Inc.: collaborator

Study Sites (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Lung Diseases

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Mario Gasparri, MD
• Organization: MEDICAL COLLEGE OF WISCONSIN

mgasparr@mcw.edu

414-955-6914

Study Officials

• Mario Gasparri, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: February 15, 2022
• Primary Completion: October 4, 2024
• Study Completion: December 31, 2024
• Last Updated: April 15, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-03

Locations

US (1)