Pain, PostoperativePhase 4NCT05144828
Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection
A Phase 4 study testing Intercostal Nerve Cryoablation in people with Pain, Postoperative and Lung Diseases, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a single center, single surgeon, prospective, randomized trial examining the addition of Cryo Nerve Block during robot assisted thoracoscopic anatomic lung resection surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative, Lung Diseases
- What is being tested?
- Intercostal Nerve Cryoablation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years of age
- Acceptable surgical candidate
- Willing and able to return for scheduled follow-up visits
Who cannot join
- Patients undergoing or requiring conversion to thoracotomy
- Patients with chronic pain syndromes requiring treatment within the last year
- Patients with a history of illicit drug use
- Patients with a history of heavy alcohol use in the last five years as determined by the principal investigator
- Patients currently using opioids
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection
This is a single center, single surgeon, prospective, randomized trial examining the addition of Cryo Nerve Block during robot assisted thoracoscopic anatomic lung resection surgery
Read the detailed description
Thoracic surgical procedures are consistently reported to be among the most painful surgical incisions currently used. Trauma to the skin, muscle, intercostal nerves, bones and pleura all contribute and lead to activation of various pain pathways including somatic, visceral, neurogenic and phrenic. In the short term, this pain leads to ineffective cough and pulmonary hygiene resulting in respiratory complications and prolonged hospital stays while in the longer term it leads to prolonged recovery, delayed return to work and in some instances, chronic post thoracotomy pain syndromes. Minimally invasive approaches such as standard thoracoscopy or robotic assisted thoracoscopy have certainly decreased some of this trauma as evidenced by decreased length of stays and decreased complication rates however even with these minimally invasive techniques, recovery to 80% of baseline is 25 days and 9.4% of patients are still using narcotics after 90-180 days.
Several options are available in the management of pain following thoracic surgery with a multimodal pain medicine approach being most common. Opioids, unfortunately, are a relatively large part of this approach and are often relied upon despite their relatively unfavorable adverse event profile and risk for addiction. Many of the other pain adjuncts often used with thoracotomies such as epidural catheters or intraoperatively placed pain catheters are not really reasonable when using minimally invasive approaches as the hospital length of stay is 1-2 days. Intercostal cryoanalgesia has been shown to be a safe and effective strategy for postoperative pain management in patients undergoing thoracotomy. Recent studies have demonstrated the beneficial effect of cryoanalgesia for post-thoracotomy pain in reduction of opioid requirement, reduction in post-operative pain scores, and superior pulmonary function (higher FEV1 and FVC values)5 and that it can produce temporary neurolysis for up to two months without long-term histological nerve damage. To date it has not been studied when using minimally invasive techniques whether it be standard thoracoscopy or robotic assisted thoracoscopy but it would stand to reason that it would be equally or maybe more effective in this patient population and truly maximize the benefits of a minimally invasive approach.
We therefore propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe provides superior post-operative analgesia as compared to our current standard pain management strategy in patients undergoing robotic assisted thoracoscopic anatomic lung resection and allows for decreased opioid use and more rapid recovery.
- Conditions
- Pain, Postoperative, Lung Diseases
- Being tested
- Intercostal Nerve Cryoablation, Patient-controlled analgesia (PCA)
- Keywords
- Atricure, CryoNB, cryoanalgesia, Medical College of Wisconsin
- Medical subject headings
- Pain, Postoperative, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal Nerve CryoablationDevice
Also called CryoICE CRYOS-L cryoablation probes (Atricure, Inc.)
Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYOS-L cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.
Patient-controlled analgesia (PCA)Drug
Patients will have access to the standard PCA (patient-controlled analgesia) offered at Froedtert Hospital. This includes tylenol 650 mg oral, robaxin 500 mg oral, and tramadol 25-50 mg oral. All patients will have the first two ports placed at which time an intercostal nerve block of nerves 4-9 will be performed using 0.5% Marcaine with Epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control | Experimental | Intercostal nerve cryoablation using the CryoICE® CRYOS-L cryoablation probe and an intercostal nerve block of nerves 4-9 performed using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin Receives: Device: Intercostal Nerve Cryoablation; Drug: Patient-controlled analgesia (PCA) |
| Standard of Care (SOC) Pain Control | Active comparator | Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin Receives: Drug: Patient-controlled analgesia (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale (VAS) Pain Score
The visual analogue scale is a pain assessment tool intended to help patient care providers assess pain according to individual patient needs. A 0-10 scale is used for patient self-assessment with 0 meaning no pain and 10 meaning worst possible pain.
Measured: 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180
Pain Medication Use
Patients will be asked about their pain medication use daily for 21 days following surgery. Total mg of postoperative pain medication taken will be collected.
Measured: 21 Days post-operatively
Secondary outcomes (2)
M.D. Anderson Symptom Inventory (MDASI) Score
The MD Anderson Symptom Inventory (MDASI) is a multi-symptom patient-reported outcome (PRO) measure for clinical and research use. The inventory assesses severity of multiple symptoms and the impact of symptoms on daily functioning during the last 24 hours. The MDASI contains 13 core symptom items that assess the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical rating scale per question, with 0 being "not present" and 10 being "as bad as you can imagine." The mean score symptom severity (of the 13 core symptom items with totals ranging between 0 and 130 per survey) will be calculated based on the sum of each survey, with a higher score indicating a higher severity of symptoms and a lower score indicating a lower severity of symptoms.
Measured: Screening, Day 1, Day 7, Day 14, Day 21, Day 30, Day 35, Day 42
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale is an assessment tool to analyze and classify pain. The primary purpose of this test is to assess whether the pain experienced is predominantly due to nerve damage or not. The LANSS comprises of a 7-item pain scale, including sensory descriptors and items for sensory examination. Each of the 7 items is awarded a number of points, depending on the answer choice. In general, answers like no or that signal normal function are awarded 0 points and those that signal a pain related symptom or sign are awarded a number of points varying from 1 to 5, depending on the severity of the particular sign. The final score ranges from 0 to 24. The interpretation is that patients with scores below 12 are less likely to carry a neuropathic cause for their pain whilst in the case of patients scoring 12 or more, there is a higher chance for the underlying mechanism to be neuropathic.
Measured: Screening, Day 30, Day 60, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Feb 2022
- Primary completion4 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Principal investigator, Mario Gasparri, MD, Medical College of Wisconsin
- Investigators
- Mario Gasparri, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144828
- Sponsor's protocol ID
- PRO40665
- Status last verified
- Mar 2026
- First submitted
- 22 Nov 2021
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intercostal CryoAnalgesia in Patients Undergoing Robot Assisted Anatomic Lung Resection
- ClinicalTrials.gov ID
- NCT05144828
- Acronym / sponsor ID
- PRO40665
- Conditions
- Pain, Postoperative, Lung Diseases
- Keywords
- Atricure, CryoNB, cryoanalgesia, Medical College of Wisconsin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, single surgeon, prospective, randomized trial examining the addition of Cryo Nerve Block during robot assisted thoracoscopic anatomic lung resection surgery
Detailed description
Thoracic surgical procedures are consistently reported to be among the most painful surgical incisions currently used. Trauma to the skin, muscle, intercostal nerves, bones and pleura all contribute and lead to activation of various pain pathways including somatic, visceral, neurogenic and phrenic. In the short term, this pain leads to ineffective cough and pulmonary hygiene resulting in respiratory complications and prolonged hospital stays while in the longer term it leads to prolonged recovery, delayed return to work and in some instances, chronic post thoracotomy pain syndromes. Minimally invasive approaches such as standard thoracoscopy or robotic assisted thoracoscopy have certainly decreased some of this trauma as evidenced by decreased length of stays and decreased complication rates however even with these minimally invasive techniques, recovery to 80% of baseline is 25 days and 9.4% of patients are still using narcotics after 90-180 days.
Several options are available in the management of pain following thoracic surgery with a multimodal pain medicine approach being most common. Opioids, unfortunately, are a relatively large part of this approach and are often relied upon despite their relatively unfavorable adverse event profile and risk for addiction. Many of the other pain adjuncts often used with thoracotomies such as epidural catheters or intraoperatively placed pain catheters are not really reasonable when using minimally invasive approaches as the hospital length of stay is 1-2 days. Intercostal cryoanalgesia has been shown to be a safe and effective strategy for postoperative pain management in patients undergoing thoracotomy. Recent studies have demonstrated the beneficial effect of cryoanalgesia for post-thoracotomy pain in reduction of opioid requirement, reduction in post-operative pain scores, and superior pulmonary function (higher FEV1 and FVC values)5 and that it can produce temporary neurolysis for up to two months without long-term histological nerve damage. To date it has not been studied when using minimally invasive techniques whether it be standard thoracoscopy or robotic assisted thoracoscopy but it would stand to reason that it would be equally or maybe more effective in this patient population and truly maximize the benefits of a minimally invasive approach.
We therefore propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe provides superior post-operative analgesia as compared to our current standard pain management strategy in patients undergoing robotic assisted thoracoscopic anatomic lung resection and allows for decreased opioid use and more rapid recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control | Experimental | Device: Intercostal Nerve Cryoablation, Drug: Patient-controlled analgesia (PCA)Intercostal nerve cryoablation using the CryoICE® CRYOS-L cryoablation probe and an intercostal nerve block of nerves 4-9 performed using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin |
| Standard of Care (SOC) Pain Control | Active comparator | Drug: Patient-controlled analgesia (PCA)Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-85 years of age
- Acceptable surgical candidate
- Willing and able to return for scheduled follow-up visits
Key exclusion criteria (5 listed)
- Patients undergoing or requiring conversion to thoracotomy
- Patients with chronic pain syndromes requiring treatment within the last year
- Patients with a history of illicit drug use
- Patients with a history of heavy alcohol use in the last five years as determined by the principal investigator
- Patients currently using opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intercostal Nerve CryoablationAlso: CryoICE CRYOS-L cryoablation probes (Atricure, Inc.)Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYOS-L cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure. | Device | Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control |
| Patient-controlled analgesia (PCA)Patients will have access to the standard PCA (patient-controlled analgesia) offered at Froedtert Hospital. This includes tylenol 650 mg oral, robaxin 500 mg oral, and tramadol 25-50 mg oral. All patients will have the first two ports placed at which time an intercostal nerve block of nerves 4-9 will be performed using 0.5% Marcaine with Epinephrine. | Drug | Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control, Standard of Care (SOC) Pain Control |
Primary outcome
Change in Visual Analogue Scale (VAS) Pain Score
Time frame: 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180
The visual analogue scale is a pain assessment tool intended to help patient care providers assess pain according to individual patient needs. A 0-10 scale is used for patient self-assessment with 0 meaning no pain and 10 meaning worst possible pain.
Pain Medication Use
Time frame: 21 Days post-operatively
Patients will be asked about their pain medication use daily for 21 days following surgery. Total mg of postoperative pain medication taken will be collected.
2 secondary outcomes
M.D. Anderson Symptom Inventory (MDASI) Score
Time frame: Screening, Day 1, Day 7, Day 14, Day 21, Day 30, Day 35, Day 42
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Time frame: Screening, Day 30, Day 60, Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Gasparri, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intercostal Nerve Cryoablation in people with Pain, Postoperative and Lung Diseases, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale (VAS) Pain Score (time frame: 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.