Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05348447
• Other study ID #: 2021-238
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: July 7, 2025

Study information

• Verified date: May 2024
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: July 7, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cryotherapy Effect
• Pain, Postoperative

Intervention

Device:
• cryoanalgesia
intraoperative intercostal nerve freezing for post-operative pain control

Other:
• Standard of Care Pain Control
Standard of Care Pain Control Post-operatively

Locations

Country	Name	City	State
United States	AHN Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine dose	total milligrams (mg) of morphine received during hospitalization	to discharge (up to 14 days)
Primary	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	pulmonary complications	Pulmonary complications as defined by the Society of Thoracic Surgeons database	through 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Incentive Spirometer Volume	The highest number (breath volume) achieved on exhalation using the incentive spirometer	to discharge (up to 14 days)
Secondary	Hospital length of stay	Number of days spent in hospital postoperatively	to discharge (up to 14 days)