Trial Outcomes & Findings for Cryoanalgesia vs. Epidural in the Nuss Procedure (NCT NCT02721017)
NCT ID: NCT02721017
Last Updated: 2021-05-05
Results Overview
the length of the patient's in-hospital stay following admission for Nuss procedure
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
estimated one week or less
Results posted on
2021-05-05
Participant Flow
Twenty consecutive patients were recruited from those scheduled for the Nuss procedure.
Exclusion criteria were age \<13 years, chest wall anomaly other than pectus excavatum, previous repair or other thoracic surgery, and chronic use of pain medications.
Participant milestones
| Measure |
Cryoanalgesia
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure
Cryoanalgesia
|
Thoracic Epidural
Thoracic epidural (ropivicaine, fentanyl).
Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
|
|---|---|---|
|
Hospital Stay
STARTED
|
10
|
10
|
|
Hospital Stay
COMPLETED
|
10
|
10
|
|
Hospital Stay
NOT COMPLETED
|
0
|
0
|
|
Participant Follow Up
STARTED
|
10
|
10
|
|
Participant Follow Up
COMPLETED
|
10
|
10
|
|
Participant Follow Up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cryoanalgesia
n=10 Participants
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure
Cryoanalgesia
|
Thoracic Epidural
n=10 Participants
Thoracic epidural (ropivicaine, fentanyl).
Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
20.9 years
n=10 Participants
|
16.1 years
n=10 Participants
|
18.5 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: estimated one week or lessthe length of the patient's in-hospital stay following admission for Nuss procedure
Outcome measures
| Measure |
Cryoanalgesia
n=10 Participants
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure.
|
Thoracic Epidural
n=10 Participants
Thoracic epidural (ropivicaine, fentanyl).
Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
|
|---|---|---|
|
Length of Hospitalization
|
3 Length of Stay (Post-Operative Days)
Interval 2.0 to 4.0
|
5 Length of Stay (Post-Operative Days)
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Post Operative Hospital StayInpatient narcotic usage
Outcome measures
| Measure |
Cryoanalgesia
n=10 Participants
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure.
|
Thoracic Epidural
n=10 Participants
Thoracic epidural (ropivicaine, fentanyl).
Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
|
|---|---|---|
|
Narcotic Usage
|
268 mg
Standard Deviation 165.2
|
684 mg
Standard Deviation 191.8
|
SECONDARY outcome
Timeframe: one yearNeuropathic specific pain (described as "burning", "electrical" or "tingling" sensations) was assessed by study questionnaire via numerical pain scale (1 to 10, with 10 representing a maximum score, or worst pain possible).
Outcome measures
| Measure |
Cryoanalgesia
n=10 Participants
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure.
|
Thoracic Epidural
n=10 Participants
Thoracic epidural (ropivicaine, fentanyl).
Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
|
|---|---|---|
|
Mean Neuropathic Pain Score at One Year
|
2.4 score on a scale
Standard Deviation 2.69
|
1.9 score on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: estimated one weekPopulation: Cost analysis was not performed, as these data were not collected.
cost analysis of initial hospitalization following Nuss procedure
Outcome measures
Outcome data not reported
Adverse Events
Cryoanalgesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thoracic Epidural
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cryoanalgesia
n=10 participants at risk
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure
Cryoanalgesia
|
Thoracic Epidural
n=10 participants at risk
Thoracic epidural (ropivicaine, fentanyl).
Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
|
|---|---|---|
|
Nervous system disorders
Paraplegia
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
|
Respiratory, thoracic and mediastinal disorders
Symptomatic Pneumothorax
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
10.0%
1/10 • Number of events 1 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
10.0%
1/10 • Number of events 1 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
|
Infections and infestations
Infection from indwelling thoracic epidural catheter
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
0.00%
0/10 • All adverse events reported post operatively at the 2 week, 1 month, 3 month and 1 year follow up points were collected. In addition all serious adverse events that occurred following enrollment were as well collected. The collection period for all serious adverse events began after informed consent was obtained and ended after procedures for the final study visit had been completed at the 1 year post-operative mark.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Benjamin Padilla
University of California San Francisco Department of Surgery
Phone: 415-476-3642
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place