Trial Outcomes & Findings for Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain (NCT NCT01560429)
NCT ID: NCT01560429
Last Updated: 2016-07-21
Results Overview
Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
48 hours postoperatively
Results posted on
2016-07-21
Participant Flow
Patients were enrolled prior to thoracotomy. 52 patients were randomized to receive PCEA (n=26) or CEA (n=26).
Participant milestones
| Measure |
Patient-controlled Epidural Analgesia
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
|
Continuous Epidural Analgesia
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Patient-controlled Epidural Analgesia
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
|
Continuous Epidural Analgesia
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
6
|
Baseline Characteristics
Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain
Baseline characteristics by cohort
| Measure |
Patient-controlled Epidural Analgesia
n=23 Participants
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
|
Continuous Epidural Analgesia
n=20 Participants
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Between 18 and 65 years
|
60.8 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
56.7 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
58 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Age, Continuous
>=65 years
|
70.9 years
STANDARD_DEVIATION 4.1 • n=99 Participants
|
70.6 years
STANDARD_DEVIATION 3.1 • n=107 Participants
|
70.8 years
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 6.1 • n=99 Participants
|
62.7 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
23 participants
n=99 Participants
|
20 participants
n=107 Participants
|
43 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hours postoperativelyAmount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.
Outcome measures
| Measure |
Patient-controlled Epidural Analgesia
n=23 Participants
An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
|
Continuous Epidural Analgesia
n=20 Participants
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
|
|---|---|---|
|
Local Anesthetic Consumption
|
1505.39 ug
Standard Error 339.43
|
1862.16 ug
Standard Error 493.85
|
PRIMARY outcome
Timeframe: 4,8,12, 24 and 48 hours postoperativelyamount of anesthetic consumed was calculated for each group over time.
Outcome measures
| Measure |
Patient-controlled Epidural Analgesia
n=23 Participants
An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
|
Continuous Epidural Analgesia
n=20 Participants
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
|
|---|---|---|
|
Anesthetic Consumption (mg)
|
158.9 mg
Standard Error 73.5
|
181.5 mg
Standard Error 73.5
|
SECONDARY outcome
Timeframe: 48 hours postoperativelyworst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 \& 48 hours following surgery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours postoperativelyWorst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy
Outcome measures
Outcome data not reported
Adverse Events
Patient-controlled Epidural Analgesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Epidural Analgesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place