Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2025-07-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Cryotherapy Effect Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

participants will be blinded to treatment group and will be sedated (part of standard of care surgery) at the time the treatment occurs

Study Groups

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Cryoanalgesia with standard of care pain control

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

Group Type EXPERIMENTAL

cryoanalgesia

Intervention Type DEVICE

intraoperative intercostal nerve freezing for post-operative pain control

Standard of Care Pain Control

Intervention Type OTHER

Standard of Care Pain Control Post-operatively

Standard of care pain control

subjects will receive standard of care pain control only

Group Type ACTIVE_COMPARATOR

Standard of Care Pain Control

Intervention Type OTHER

Standard of Care Pain Control Post-operatively

Interventions

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cryoanalgesia

intraoperative intercostal nerve freezing for post-operative pain control

Intervention Type DEVICE

Standard of Care Pain Control

Standard of Care Pain Control Post-operatively

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No