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Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Primary Purpose

Cryotherapy Effect, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryoanalgesia
Standard of Care Pain Control
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryotherapy Effect focused on measuring pulmonary, resection, cryotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AHN Allegheny General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryoanalgesia with standard of care pain control

Standard of care pain control

Arm Description

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

subjects will receive standard of care pain control only

Outcomes

Primary Outcome Measures

Total morphine dose
total milligrams (mg) of morphine received during hospitalization
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

Secondary Outcome Measures

pulmonary complications
Pulmonary complications as defined by the Society of Thoracic Surgeons database
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
total morphine equivalent dose of narcotics
total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively
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
Incentive Spirometer Volume
The highest number (breath volume) achieved on exhalation using the incentive spirometer
Hospital length of stay
Number of days spent in hospital postoperatively

Full Information

First Posted
April 15, 2022
Last Updated
August 23, 2023
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
AtriCure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05348447
Brief Title
Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
Official Title
Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
October 7, 2023 (Anticipated)
Study Completion Date
October 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
AtriCure, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy Effect, Pain, Postoperative
Keywords
pulmonary, resection, cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
participants will be blinded to treatment group and will be sedated (part of standard of care surgery) at the time the treatment occurs
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryoanalgesia with standard of care pain control
Arm Type
Experimental
Arm Description
subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery
Arm Title
Standard of care pain control
Arm Type
Active Comparator
Arm Description
subjects will receive standard of care pain control only
Intervention Type
Device
Intervention Name(s)
cryoanalgesia
Intervention Description
intraoperative intercostal nerve freezing for post-operative pain control
Intervention Type
Other
Intervention Name(s)
Standard of Care Pain Control
Intervention Description
Standard of Care Pain Control Post-operatively
Primary Outcome Measure Information:
Title
Total morphine dose
Description
total milligrams (mg) of morphine received during hospitalization
Time Frame
to discharge (up to 14 days)
Title
Pain control
Description
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
Time Frame
to discharge (up to 14 days)
Secondary Outcome Measure Information:
Title
pulmonary complications
Description
Pulmonary complications as defined by the Society of Thoracic Surgeons database
Time Frame
through 1 year
Title
pain control
Description
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
Time Frame
2 weeks and 3 months post-operatively
Title
total morphine equivalent dose of narcotics
Description
total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively
Time Frame
2 weeks and 3 months post-operatively
Title
Presence of neuropathy in the surgical site
Description
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
Time Frame
2 weeks, 3 months, 6 months and 1 year postoperatively
Title
Incentive Spirometer Volume
Description
The highest number (breath volume) achieved on exhalation using the incentive spirometer
Time Frame
to discharge (up to 14 days)
Title
Hospital length of stay
Description
Number of days spent in hospital postoperatively
Time Frame
to discharge (up to 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benny Weksler, MD
Phone
412-359-8133
Email
benny.weksler@ahn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Contact
Phone
412-330-6151
Email
clinicaltrials@ahn.org
Facility Information:
Facility Name
AHN Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Schwarz
Phone
412-578-1035
Email
meredith.schwarz@ahn.org
First Name & Middle Initial & Last Name & Degree
Clinical Trials Contact
Phone
412-330-6151
Email
clinicaltrials@ahn.org
First Name & Middle Initial & Last Name & Degree
Hiran Fernando, MD

12. IPD Sharing Statement

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Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

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