Trial Outcomes & Findings for Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient (NCT NCT01816477)
NCT ID: NCT01816477
Last Updated: 2017-04-04
Results Overview
Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Up to 11 days post operation
Results posted on
2017-04-04
Participant Flow
Subjects were recruited from Mayo Clinic in Phoenix, Arizona.
Participant milestones
| Measure |
Thoracic Epidural
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
27
|
41
|
|
Overall Study
NOT COMPLETED
|
16
|
1
|
Reasons for withdrawal
| Measure |
Thoracic Epidural
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
1
|
|
Overall Study
Unable to tolerate catheter placement
|
3
|
0
|
Baseline Characteristics
Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient
Baseline characteristics by cohort
| Measure |
Thoracic Epidural
n=27 Participants
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
n=41 Participants
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
41 participants
n=7 Participants
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 11 days post operationHospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.
Outcome measures
| Measure |
Thoracic Epidural
n=27 Participants
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
n=41 Participants
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
|---|---|---|
|
Hospital Length of Stay
|
3.5 days
Standard Deviation 0.9
|
3.3 days
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 1-7 days post operationPopulation: The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q). The protocol had planned to use the area under the curve, but this was not analyzed in the published paper, due to the presence of missing data in the analgesic narcotic measurements.
Postoperative analgesic used each day over 7 day postoperative period.
Outcome measures
| Measure |
Thoracic Epidural
n=27 Participants
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
n=41 Participants
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
|---|---|---|
|
Use of Analgesic Narcotic
Day 1 (n = 27, 41)
|
40.8 morphine milligram equivalents
Standard Deviation 38.5
|
58.7 morphine milligram equivalents
Standard Deviation 45.8
|
|
Use of Analgesic Narcotic
Day 2 (n = 27, 41)
|
99.5 morphine milligram equivalents
Standard Deviation 71.1
|
107.2 morphine milligram equivalents
Standard Deviation 76.1
|
|
Use of Analgesic Narcotic
Day 3 (n = 27, 41)
|
79.7 morphine milligram equivalents
Standard Deviation 42.7
|
62.4 morphine milligram equivalents
Standard Deviation 46.9
|
|
Use of Analgesic Narcotic
Day 4 (n = 24, 27)
|
65.8 morphine milligram equivalents
Standard Deviation 46.1
|
79.4 morphine milligram equivalents
Standard Deviation 57.8
|
|
Use of Analgesic Narcotic
Day 5 (n = 12, 13)
|
43.5 morphine milligram equivalents
Standard Deviation 33.4
|
78.8 morphine milligram equivalents
Standard Deviation 54.2
|
|
Use of Analgesic Narcotic
Day 6 (n = 3, 5)
|
30.8 morphine milligram equivalents
Standard Deviation 27.4
|
86.4 morphine milligram equivalents
Standard Deviation 31.9
|
|
Use of Analgesic Narcotic
Day 7 (n = 1, 3)
|
24.0 morphine milligram equivalents
Standard Deviation NA
One participant in the Epidural arm was using an analgesic narcotic on Day 7; a standard deviation cannot be calculated for one participant.
|
81.9 morphine milligram equivalents
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Days 1-7 post operationPopulation: The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q).
Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged.
Outcome measures
| Measure |
Thoracic Epidural
n=27 Participants
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
n=41 Participants
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
|---|---|---|
|
Mean Daily Pain Score
Day 1 (n = 27, 41)
|
2.19 units on a scale
Standard Deviation 1.76
|
2.39 units on a scale
Standard Deviation 1.72
|
|
Mean Daily Pain Score
Day 2 (n = 27, 41)
|
2.64 units on a scale
Standard Deviation 1.41
|
2.60 units on a scale
Standard Deviation 1.40
|
|
Mean Daily Pain Score
Day 3 (n = 27, 41)
|
3.16 units on a scale
Standard Deviation 1.31
|
2.97 units on a scale
Standard Deviation 1.36
|
|
Mean Daily Pain Score
Day 4 (n = 24, 27)
|
3.03 units on a scale
Standard Deviation 1.25
|
3.60 units on a scale
Standard Deviation 1.19
|
|
Mean Daily Pain Score
Day 5 (n = 12, 13)
|
2.95 units on a scale
Standard Deviation 1.22
|
3.30 units on a scale
Standard Deviation 1.50
|
|
Mean Daily Pain Score
Day 6 (n = 3, 5)
|
3.28 units on a scale
Standard Deviation 0.25
|
3.55 units on a scale
Standard Deviation 1.52
|
|
Mean Daily Pain Score
Day 7 (n=1, 3)
|
4.50 units on a scale
Standard Deviation NA
One participant in the Epidural arm provided a pain score on Day 7; a standard deviation cannot be calculated for one participant.
|
4.13 units on a scale
Standard Deviation 1.65
|
Adverse Events
Thoracic Epidural
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ON-Q Soaker Catheter System
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thoracic Epidural
n=30 participants at risk
Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
|
ON-Q Soaker Catheter System
n=55 participants at risk
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
1.8%
1/55 • Number of events 1 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion requiring thoracentesis
|
0.00%
0/30 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
5.5%
3/55 • Number of events 3 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax requiring chest tube
|
3.3%
1/30 • Number of events 1 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
0.00%
0/55 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
3.6%
2/55 • Number of events 2 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
|
Renal and urinary disorders
Urinary retention requiring catheter placement
|
6.7%
2/30 • Number of events 2 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
9.1%
5/55 • Number of events 5 • Adverse event reports were collected from the day of the operation up to postoperative day 7.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place