Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.

There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Cryotherapy Effect
• Intervention / Treatment: Device: cryoanalgesia; Other: Standard of Care Pain Control

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benny Weksler, MD; Phone Number: 412-359-8133; Email: benny.weksler@ahn.org
• Study Contact Backup: Name: Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • AHN Allegheny General Hospital
      • Contact: Meredith Schwarz; Phone Number: 412-578-1035; Email: meredith.schwarz@ahn.org
      • Sub-Investigator: Hiran Fernando, MD
      • Contact: Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 18 year and older.
2. Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
3. Performance status of 1 or 2.

Exclusion Criteria:

1. Patients with ejection fraction less than 40%
2. Patients with creatinine greater than 1.5.
3. Patients with Child's B or C cirrhosis
4. Patients on chronic narcotics for other reasons
5. Patients diagnosed with fibromyalgia
6. Patients who had previous thoracic surgery on the same side.
7. Patients who cannot communicate in English.
8. Patients unable to provide informed consent for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoanalgesia with standard of care pain control; subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery	Device: cryoanalgesia; intraoperative intercostal nerve freezing for post-operative pain control; Other: Standard of Care Pain Control; Standard of Care Pain Control Post-operatively
Active Comparator: Standard of care pain control; subjects will receive standard of care pain control only	Other: Standard of Care Pain Control; Standard of Care Pain Control Post-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine dose	total milligrams (mg) of morphine received during hospitalization	to discharge (up to 14 days)
Pain control	Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome	to discharge (up to 14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary complications	Pulmonary complications as defined by the Society of Thoracic Surgeons database	through 1 year
pain control	Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome	2 weeks and 3 months post-operatively
total morphine equivalent dose of narcotics	total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively	2 weeks and 3 months post-operatively
Presence of neuropathy in the surgical site	physician will assess by modified treatment-induced neuropathy scale (0-10), with higher scores meaning a worse outcome; The modified questionnaire will assess the following symptoms and ask patients to score those symptoms from 0 (not present) to 10 (unbearable): Numbness at or near the incision site (including chest wall); Tingling at or near the incision site; Pain at or near the incision site; Hot or burning sensation at or near the incision site; Feeling of coldness at or near the incision site	2 weeks, 3 months, 6 months and 1 year postoperatively
Incentive Spirometer Volume	The highest number (breath volume) achieved on exhalation using the incentive spirometer	to discharge (up to 14 days)
Hospital length of stay	Number of days spent in hospital postoperatively	to discharge (up to 14 days)

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): July 7, 2025

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cryotherapy; resection; pulmonary
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2021-238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No