Trial Outcomes & Findings for A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair (NCT NCT02056301)
NCT ID: NCT02056301
Last Updated: 2020-06-11
Results Overview
The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain scores during postoperative days (POD) 0-4. Pain was measured using the verbal pain scale. The scale ranges from 0-10. A score of 0 means the patient is in no pain.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Postoperative days 0-4
Results posted on
2020-06-11
Participant Flow
Participant milestones
| Measure |
Patient Controlled Analgesia
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
29
|
|
Overall Study
COMPLETED
|
31
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Patient Controlled Analgesia
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Surgical complications req. 2nd surgery
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Issues with epidural
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patient Controlled Analgesia
n=31 Participants
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
n=23 Participants
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.7 years
n=31 Participants
|
16.0 years
n=23 Participants
|
15.8 years
n=54 Participants
|
|
Sex/Gender, Customized
Male
|
26 Participants
n=31 Participants
|
21 Participants
n=23 Participants
|
47 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=31 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Unknown
|
2 Participants
n=31 Participants
|
1 Participants
n=23 Participants
|
3 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
23 participants
n=23 Participants
|
54 participants
n=54 Participants
|
|
ASA Status
ASA I
|
8 Participants
n=31 Participants
|
7 Participants
n=23 Participants
|
15 Participants
n=54 Participants
|
|
ASA Status
ASA II
|
20 Participants
n=31 Participants
|
15 Participants
n=23 Participants
|
35 Participants
n=54 Participants
|
|
ASA Status
ASA III
|
1 Participants
n=31 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=54 Participants
|
|
ASA Status
ASA IV
|
0 Participants
n=31 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=54 Participants
|
|
ASA Status
ASA V
|
0 Participants
n=31 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=54 Participants
|
|
ASA Status
ASA VI
|
0 Participants
n=31 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=54 Participants
|
|
ASA Status
Unknown
|
2 Participants
n=31 Participants
|
1 Participants
n=23 Participants
|
3 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Postoperative days 0-4Population: Pain scores could not be collected on each post-operative day because some subjects were discharged from the hospital quicker than others.
The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain scores during postoperative days (POD) 0-4. Pain was measured using the verbal pain scale. The scale ranges from 0-10. A score of 0 means the patient is in no pain.
Outcome measures
| Measure |
Patient Controlled Analgesia
n=29 Participants
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
n=21 Participants
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Verbal Pain Scale Scores During Postoperative Days 0-4
Post-Operative Day 0
|
3.69 units on a scale
Standard Deviation 1.98
|
2.28 units on a scale
Standard Deviation 1.63
|
|
Verbal Pain Scale Scores During Postoperative Days 0-4
Post-Operative Day 1
|
2.77 units on a scale
Standard Deviation 2.19
|
1.11 units on a scale
Standard Deviation 1.18
|
|
Verbal Pain Scale Scores During Postoperative Days 0-4
Post-Operative Day 2
|
2.25 units on a scale
Standard Deviation 1.65
|
2.14 units on a scale
Standard Deviation 1.8
|
|
Verbal Pain Scale Scores During Postoperative Days 0-4
Post-Operative Day 3
|
2.69 units on a scale
Standard Deviation 1.33
|
2.73 units on a scale
Standard Deviation 1.85
|
|
Verbal Pain Scale Scores During Postoperative Days 0-4
Post-Operative Day 4
|
2.24 units on a scale
Standard Deviation 1.52
|
2.14 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Postoperative days 0-4Population: Total Morphine Equivalent Consumption could not be collected on each post-operative day for every subject because some subjects were discharged from the hospital quicker than others.
This outcome measures total amount of morphine administered in mg/kg by post-operative day 0-4. This captures all standard of care opioids delivered via their assigned cohort route (Epidural vs. IV PCA). Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.
Outcome measures
| Measure |
Patient Controlled Analgesia
n=31 Participants
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
n=23 Participants
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Total Morphine Equivalent Consumption During Postoperative Days 0-4
Day 0
|
0.75 mg/kg
Standard Deviation 0.34
|
0.14 mg/kg
Standard Deviation 0.06
|
|
Total Morphine Equivalent Consumption During Postoperative Days 0-4
Day 1
|
0.90 mg/kg
Standard Deviation 0.42
|
0.23 mg/kg
Standard Deviation 0.12
|
|
Total Morphine Equivalent Consumption During Postoperative Days 0-4
Day 2
|
0.67 mg/kg
Standard Deviation 0.33
|
0.61 mg/kg
Standard Deviation 0.34
|
|
Total Morphine Equivalent Consumption During Postoperative Days 0-4
Day 3
|
0.57 mg/kg
Standard Deviation 0.36
|
0.92 mg/kg
Standard Deviation 0.23
|
|
Total Morphine Equivalent Consumption During Postoperative Days 0-4
Day 4
|
0.39 mg/kg
Standard Deviation 0.32
|
0.45 mg/kg
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Postoperative days 0-4Population: Total Morphine Equivalent Consumption could not be collected on each post-operative day for every subject because some subjects were discharged from the hospital quicker than others.
This outcome measures the amount of rescue morphine administered due to breakthrough pain in mg/kg by post-operative day 0-4. This captures additional opioids that were administered by a nurse through an IV. Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.
Outcome measures
| Measure |
Patient Controlled Analgesia
n=31 Participants
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
n=23 Participants
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Rescue Morphine Equivalent Administration During Postoperative Days 0-4
Day 3
|
0.07 mg/kg
Standard Deviation 0.26
|
0.39 mg/kg
Standard Deviation 0.94
|
|
Rescue Morphine Equivalent Administration During Postoperative Days 0-4
Day 0
|
1.26 mg/kg
Standard Deviation 0.89
|
0.57 mg/kg
Standard Deviation 0.73
|
|
Rescue Morphine Equivalent Administration During Postoperative Days 0-4
Day 1
|
0.23 mg/kg
Standard Deviation 0.67
|
0.26 mg/kg
Standard Deviation 0.69
|
|
Rescue Morphine Equivalent Administration During Postoperative Days 0-4
Day 2
|
0.13 mg/kg
Standard Deviation 0.50
|
0.70 mg/kg
Standard Deviation 1.15
|
|
Rescue Morphine Equivalent Administration During Postoperative Days 0-4
Day 4
|
0.05 mg/kg
Standard Deviation 0.23
|
0.10 mg/kg
Standard Deviation 0.44
|
Adverse Events
Patient Controlled Analgesia
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Epidural Catheter
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient Controlled Analgesia
n=33 participants at risk
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
n=29 participants at risk
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Surgical and medical procedures
Surgical Complications
|
3.0%
1/33 • Number of events 1 • Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.
|
0.00%
0/29 • Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.
|
Other adverse events
| Measure |
Patient Controlled Analgesia
n=33 participants at risk
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
|
Epidural Catheter
n=29 participants at risk
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
|
|---|---|---|
|
Surgical and medical procedures
Epidural Related
|
9.1%
3/33 • Number of events 3 • Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.
|
10.3%
3/29 • Number of events 3 • Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place