Trial Outcomes & Findings for Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas (NCT NCT01438476)
NCT ID: NCT01438476
Last Updated: 2020-02-12
Results Overview
The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
178 participants
Primary outcome timeframe
First 48 hours after surgery
Results posted on
2020-02-12
Participant Flow
During the study period, 178 screened patients were initially eligible for inclusion to the randomized controlled trial.
Among the 178 eligible patients, 38 patients were excluded due to withdrawal of consent, development of exclusion criteria and/or the finding of unresectable disease at surgery. The study concluded with 140 patients eligible for analysis, with 106 patients allocated to the TEA group and 34 patients allocated to the IV-PCA group.
Participant milestones
| Measure |
TEA (Thoracic Epidural Analgesia)
Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
IV-PCA (Intravenous Patient-controlled Analgesia)
Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
45
|
|
Overall Study
COMPLETED
|
106
|
34
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
TEA (Thoracic Epidural Analgesia)
Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
IV-PCA (Intravenous Patient-controlled Analgesia)
Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
No Surgery- Disease
|
8
|
10
|
|
Overall Study
Communication barrier
|
0
|
1
|
Baseline Characteristics
Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
Baseline characteristics by cohort
| Measure |
TEA (Thoracic Epidural Analgesia)
n=106 Participants
Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
IV-PCA (Intravenous Patient-controlled Analgesia)
n=34 Participants
Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
56.3 years
n=5 Participants
|
57.4 years
n=7 Participants
|
56.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
34 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Major hepatectomy
|
70 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 48 hours after surgeryThe Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.
Outcome measures
| Measure |
TEA (Thoracic Epidural Analgesia)
n=106 Participants
Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10
|
IV-PCA (Intravenous Patient-controlled Analgesia)
n=34 Participants
Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
|---|---|---|
|
Postoperative Pain Experience
|
78.6 score on a scale* hour
Interval 49.6 to 115.3
|
105.2 score on a scale* hour
Interval 64.2 to 144.2
|
Adverse Events
TEA (Thoracic Epidural Analgesia)
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
IV-PCA (Intravenous Patient-controlled Analgesia)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEA (Thoracic Epidural Analgesia)
n=106 participants at risk
Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
IV-PCA (Intravenous Patient-controlled Analgesia)
n=34 participants at risk
Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.
|
|---|---|---|
|
Gastrointestinal disorders
Analgesia
|
12.3%
13/106 • Patients were assessed during their inpatient hospitalization average and range of length of stay for each arm is provided in the data table.
|
2.9%
1/34 • Patients were assessed during their inpatient hospitalization average and range of length of stay for each arm is provided in the data table.
|
|
Gastrointestinal disorders
Ileus
|
7.5%
8/106 • Patients were assessed during their inpatient hospitalization average and range of length of stay for each arm is provided in the data table.
|
5.9%
2/34 • Patients were assessed during their inpatient hospitalization average and range of length of stay for each arm is provided in the data table.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jean-Nicolas Vauthey,MD/Professor, Surgical Oncology
UT MD Anderson Cancer Center
Phone: 713- 792-2022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place