Trial Outcomes & Findings for Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection (NCT NCT05144828)
NCT ID: NCT05144828
Last Updated: 2026-04-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180
Results posted on
2026-04-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection
Baseline characteristics by cohort
| Measure |
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
n=17 Participants
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.
|
Standard of Care (SOC) Pain Control
n=16 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 6.3 • n=193 Participants
|
65.3 years
STANDARD_DEVIATION 13.8 • n=193 Participants
|
66.7 years
STANDARD_DEVIATION 10.4 • n=386 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
21 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
31 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=193 Participants
|
17 participants
n=193 Participants
|
33 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 14 Days post-operatively, day 30, day 60, day 90, day 120, day 150, day 180Population: Daily VIS 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.
Outcome measures
| Measure |
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
n=17 Participants
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.
|
Standard of Care (SOC) Pain Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 1
|
4.57 scores on a scale
Standard Deviation 2.28
|
6.25 scores on a scale
Standard Deviation 1.98
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 2
|
4.14 scores on a scale
Standard Deviation 2.51
|
5.44 scores on a scale
Standard Deviation 1.67
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 3
|
4.36 scores on a scale
Standard Deviation 2.53
|
5.06 scores on a scale
Standard Deviation 1.88
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 4
|
3.57 scores on a scale
Standard Deviation 2.31
|
5.00 scores on a scale
Standard Deviation 1.83
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 5
|
3.79 scores on a scale
Standard Deviation 2.36
|
4.19 scores on a scale
Standard Deviation 2.10
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 6
|
4.07 scores on a scale
Standard Deviation 2.50
|
3.56 scores on a scale
Standard Deviation 1.97
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 7
|
3.57 scores on a scale
Standard Deviation 2.24
|
3.19 scores on a scale
Standard Deviation 1.76
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 8
|
3.64 scores on a scale
Standard Deviation 2.24
|
2.94 scores on a scale
Standard Deviation 2.46
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 9
|
2.21 scores on a scale
Standard Deviation 1.81
|
2.56 scores on a scale
Standard Deviation 2.00
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 10
|
2.6 scores on a scale
Standard Deviation 1.50
|
2.75 scores on a scale
Standard Deviation 1.53
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 13
|
2.47 scores on a scale
Standard Deviation 1.51
|
2.50 scores on a scale
Standard Deviation 1.90
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 120
|
0.47 scores on a scale
Standard Deviation 0.92
|
0.67 scores on a scale
Standard Deviation 1.40
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 150
|
0.33 scores on a scale
Standard Deviation 0.82
|
0.53 scores on a scale
Standard Deviation 1.55
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 0
|
4.94 scores on a scale
Standard Deviation 2.22
|
7.50 scores on a scale
Standard Deviation 1.41
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 11
|
2.67 scores on a scale
Standard Deviation 1.95
|
2.81 scores on a scale
Standard Deviation 1.64
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 12
|
2.53 scores on a scale
Standard Deviation 1.81
|
2.50 scores on a scale
Standard Deviation 1.26
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 14
|
3.13 scores on a scale
Standard Deviation 2.20
|
2.25 scores on a scale
Standard Deviation 1.73
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 30
|
2.29 scores on a scale
Standard Deviation 1.83
|
1.20 scores on a scale
Standard Deviation 1.57
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 60
|
1.06 scores on a scale
Standard Deviation 1.00
|
1.27 scores on a scale
Standard Deviation 2.31
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 90
|
0.60 scores on a scale
Standard Deviation 0.99
|
0.60 scores on a scale
Standard Deviation 1.30
|
|
Change in Visual Analogue Scale (VAS) Pain Score
Day 180
|
0.47 scores on a scale
Standard Deviation 0.83
|
0.67 scores on a scale
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: 21 Days post-operativelyPatients will be asked about their pain medication use daily for 21 days following surgery. Total mg of postoperative pain medication taken will be collected.
Outcome measures
| Measure |
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
n=17 Participants
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.
|
Standard of Care (SOC) Pain Control
n=16 Participants
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.
|
|---|---|---|
|
Pain Medication Use
Day 0
|
6.47 mgs
Standard Deviation 11.29
|
24.38 mgs
Standard Deviation 16.21
|
|
Pain Medication Use
Day 1
|
8.24 mgs
Standard Deviation 10.89
|
23.44 mgs
Standard Deviation 17.77
|
|
Pain Medication Use
Day 7
|
2.65 mgs
Standard Deviation 4.72
|
4.69 mgs
Standard Deviation 6.94
|
|
Pain Medication Use
Day 8
|
3.82 mgs
Standard Deviation 5.74
|
3.44 mgs
Standard Deviation 6.25
|
|
Pain Medication Use
Day 19
|
0.88 mgs
Standard Deviation 1.96
|
0.94 mgs
Standard Deviation 2.72
|
|
Pain Medication Use
Day 20
|
1.03 mgs
Standard Deviation 2.35
|
0.31 mgs
Standard Deviation 1.25
|
|
Pain Medication Use
Day 2
|
3.00 mgs
Standard Deviation 6.84
|
19.69 mgs
Standard Deviation 15.65
|
|
Pain Medication Use
Day 3
|
2.65 mgs
Standard Deviation 6.40
|
16.25 mgs
Standard Deviation 14.55
|
|
Pain Medication Use
Day 4
|
2.06 mgs
Standard Deviation 5.32
|
10.63 mgs
Standard Deviation 13.52
|
|
Pain Medication Use
Day 5
|
2.06 mgs
Standard Deviation 5.32
|
9.38 mgs
Standard Deviation 11.09
|
|
Pain Medication Use
Day 6
|
2.94 mgs
Standard Deviation 6.14
|
6.88 mgs
Standard Deviation 9.29
|
|
Pain Medication Use
Day 9
|
2.65 mgs
Standard Deviation 5.34
|
3.13 mgs
Standard Deviation 6.29
|
|
Pain Medication Use
Day 10
|
1.76 mgs
Standard Deviation 4.98
|
2.50 mgs
Standard Deviation 4.83
|
|
Pain Medication Use
Day 11
|
1.47 mgs
Standard Deviation 3.86
|
2.50 mgs
Standard Deviation 4.83
|
|
Pain Medication Use
Day 12
|
1.18 mgs
Standard Deviation 2.81
|
3.75 mgs
Standard Deviation 6.45
|
|
Pain Medication Use
Day 13
|
1.18 mgs
Standard Deviation 2.19
|
3.13 mgs
Standard Deviation 6.29
|
|
Pain Medication Use
Day 14
|
1.18 mgs
Standard Deviation 2.19
|
3.44 mgs
Standard Deviation 5.98
|
|
Pain Medication Use
Day 15
|
1.47 mgs
Standard Deviation 3.86
|
2.19 mgs
Standard Deviation 5.47
|
|
Pain Medication Use
Day 16
|
1.76 mgs
Standard Deviation 3.93
|
2.50 mgs
Standard Deviation 5.48
|
|
Pain Medication Use
Day 17
|
1.47 mgs
Standard Deviation 3.86
|
1.88 mgs
Standard Deviation 4.03
|
|
Pain Medication Use
Day 18
|
0.88 mgs
Standard Deviation 1.96
|
0.94 mgs
Standard Deviation 2.72
|
|
Pain Medication Use
Day 21
|
0.74 mgs
Standard Deviation 2.12
|
0.63 mgs
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 7, Day 14, Day 21, Day 30, Day 35, Day 42Population: 1 subject was lost to follow up before the Day 30, Day 35, and Day 42 survey scores were collected
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.
Outcome measures
| Measure |
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
n=17 Participants
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.
|
Standard of Care (SOC) Pain Control
n=16 Participants
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.
|
|---|---|---|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 30
|
26.12 score on a scale
Standard Deviation 15.47
|
12.07 score on a scale
Standard Deviation 11.17
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 42
|
24 score on a scale
Standard Deviation 17.73
|
11.40 score on a scale
Standard Deviation 15.64
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Screening
|
13.82 score on a scale
Standard Deviation 12.81
|
10.88 score on a scale
Standard Deviation 9.77
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 1
|
40.47 score on a scale
Standard Deviation 20.45
|
34.50 score on a scale
Standard Deviation 21.76
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 7
|
37.53 score on a scale
Standard Deviation 20.10
|
25.19 score on a scale
Standard Deviation 14.86
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 21
|
28.59 score on a scale
Standard Deviation 18.71
|
14.63 score on a scale
Standard Deviation 13.70
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 14
|
31.18 score on a scale
Standard Deviation 22.32
|
18.94 score on a scale
Standard Deviation 12.13
|
|
M.D. Anderson Symptom Inventory (MDASI) Score
Day 35
|
22.76 score on a scale
Standard Deviation 15.46
|
13.33 score on a scale
Standard Deviation 14.45
|
SECONDARY outcome
Timeframe: Screening, Day 30, Day 60, Day 180Population: Two subjects were withdrawn after Day 30 in the cryoablation group and one subject was withdrawn before Day 30 in the SOC group.
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.
Outcome measures
| Measure |
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
n=17 Participants
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.
|
Standard of Care (SOC) Pain Control
n=16 Participants
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.
|
|---|---|---|
|
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Day 30
|
8.06 score on a scale
Standard Deviation 6.76
|
6.20 score on a scale
Standard Deviation 5.24
|
|
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Day 180
|
6.67 score on a scale
Standard Deviation 7.14
|
4.67 score on a scale
Standard Deviation 6.66
|
|
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Screening
|
0 score on a scale
Standard Deviation 0.00
|
.13 score on a scale
Standard Deviation 0.50
|
|
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Day 60
|
8.33 score on a scale
Standard Deviation 7.23
|
3.33 score on a scale
Standard Deviation 5.16
|
Adverse Events
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard of Care (SOC) Pain Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intercostal Nerve Cryoablation Plus Standard of Care (SOC) Pain Control
n=17 participants at risk
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.
|
Standard of Care (SOC) Pain Control
n=16 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Prolonged air-leak
|
17.6%
3/17 • D0 (date of procedure) through D21
|
18.8%
3/16 • D0 (date of procedure) through D21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place