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NCT Number: NCT05348447

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cryotherapy Effect Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cryoanalgesia

Device

intraoperative intercostal nerve freezing for post-operative pain control

Standard of Care Pain Control

Other

Standard of Care Pain Control Post-operatively

Primary outcomes

  1. Total morphine dose

    Time frame: to discharge (up to 14 days)

    total milligrams (mg) of morphine received during hospitalization

  2. Pain control

    Time frame: to discharge (up to 14 days)

    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

Secondary outcomes

  1. pulmonary complications

    Time frame: through 1 year

    Pulmonary complications as defined by the Society of Thoracic Surgeons database

  2. pain control

    Time frame: 2 weeks and 3 months post-operatively

    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

  3. total morphine equivalent dose of narcotics

    Time frame: 2 weeks and 3 months post-operatively

    total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively

  4. Presence of neuropathy in the surgical site

    Time frame: 2 weeks, 3 months, 6 months and 1 year postoperatively

    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

  5. Incentive Spirometer Volume

    Time frame: to discharge (up to 14 days)

    The highest number (breath volume) achieved on exhalation using the incentive spirometer

  6. Hospital length of stay

    Time frame: to discharge (up to 14 days)

    Number of days spent in hospital postoperatively

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Collaborators

  • AtriCure, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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