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| Name | Class |
|---|---|
| AtriCure, Inc. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intercostal Nerve Cryoablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 21 Days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Gasparri, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control | 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 Intercostal Nerve Cryoablation: 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): 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. |
| FG001 | Standard of Care (SOC) Pain Control | Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control | 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 Intercostal Nerve Cryoablation: 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): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Daily VIS Score | Posted | Mean | Standard Deviation | scores on a scale | 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180 |
|
D0 (date of procedure) through D21
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control | 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 Intercostal Nerve Cryoablation: 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): 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged air-leak | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Gasparri, MD | MEDICAL COLLEGE OF WISCONSIN | 414-955-6914 | mgasparr@mcw.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2022 | Oct 29, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| 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. |
|
| 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. | Screening, Day 30, Day 60, Day 180 |
| BG001 | Standard of Care (SOC) Pain Control | Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care (SOC) Pain Control | Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mgs | 21 Days post-operatively |
|
|
|
| Secondary | 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. | 1 subject was lost to follow up before the Day 30, Day 35, and Day 42 survey scores were collected | Posted | Mean | Standard Deviation | score on a scale | Screening, Day 1, Day 7, Day 14, Day 21, Day 30, Day 35, Day 42 |
|
|
|
| Secondary | 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. | Two subjects were withdrawn after Day 30 in the cryoablation group and one subject was withdrawn before Day 30 in the SOC group. | Posted | Mean | Standard Deviation | score on a scale | Screening, Day 30, Day 60, Day 180 |
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| 0 |
| 17 |
| 0 |
| 17 |
| 3 |
| 17 |
| EG001 | Standard of Care (SOC) Pain Control | Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin 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. | 0 | 16 | 0 | 16 | 3 | 16 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
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