Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Allegheny Health Network (AHN)

Status: Active, not recruiting

Conditions: Pain, Postoperative; Cryotherapy Effect

Treatments: Device: cryoanalgesia; Other: Standard of Care Pain Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05348447

2021-238

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Cryoanalgesia with standard of care pain control

Experimental group

Description:

subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery

Treatment:

Other: Standard of Care Pain Control

Device: cryoanalgesia

Standard of care pain control

Active Comparator group

Description:

subjects will receive standard of care pain control only

Treatment:

Other: Standard of Care Pain Control