Trial Outcomes & Findings for Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens (NCT NCT01249872)
NCT ID: NCT01249872
Last Updated: 2013-07-24
Results Overview
Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
96 participants
Primary outcome timeframe
up to 48 h postoperatively
Results posted on
2013-07-24
Participant Flow
Between January 2010 and September 2012, a total of 107 morbidly obese patients undergoing an open weight loss surgery (BPD-RYGBP) were assessed for eligibility, with 96 patients randomized to one of the six Groups (n=16)
From the 107 patients, assessed for eligibility, 11 patients were excluded due to: * Surgery postponed (n=3) * Decline to participate (n=2) * Prolonged surgery \>4h, due to complications (n=3) * Failure to place epidural catheter (n=3)
Participant milestones
| Measure |
GROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINE
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE
Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINE
Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens
Baseline characteristics by cohort
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intraoperatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16) receive intraoperatively (45 min before the estimated end of the surgery) an epidural bolus dose 2 mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 ml of normal saline. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
Total
n=96 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
96 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age Continuous
Age (yr)
|
35.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
35.8 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
35.1 years
STANDARD_DEVIATION 8.5 • n=10 Participants
|
34.7 years
STANDARD_DEVIATION 7.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Region of Enrollment
Greece
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
16 participants
n=4 Participants
|
16 participants
n=21 Participants
|
16 participants
n=10 Participants
|
96 participants
n=115 Participants
|
|
Body Mass Index (BMI)
|
57.8 kg/m2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
57.5 kg/m2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
58.3 kg/m2
STANDARD_DEVIATION 7.8 • n=5 Participants
|
58.6 kg/m2
STANDARD_DEVIATION 6.9 • n=4 Participants
|
60.0 kg/m2
STANDARD_DEVIATION 3.9 • n=21 Participants
|
59.4 kg/m2
STANDARD_DEVIATION 7.0 • n=10 Participants
|
58.6 kg/m2
STANDARD_DEVIATION 6.2 • n=115 Participants
|
PRIMARY outcome
Timeframe: up to 48 h postoperativelyPopulation: The sample size was chosen in order to detect a difference in the epidural levobupivacaine PCEA consumption at 48 hrs. We calculated that 14 patients per group would be adequate to detect statistical significance (α = 0.05, power = 90%), using data from a previous pilot study Then, we increased the sample size by 15%.
Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.
Outcome measures
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pain Scores (Visual Analogue Scale)
VAS rest at 24h postoperatively
|
0.1 units on a scale
Standard Deviation 0.3
|
0.4 units on a scale
Standard Deviation 0.9
|
0.4 units on a scale
Standard Deviation 1.0
|
0.0 units on a scale
Standard Deviation 0.0
|
1.8 units on a scale
Standard Deviation 2.0
|
0.1 units on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Pain Scores (Visual Analogue Scale)
VAS rest at 6h postoperatively
|
1.4 units on a scale
Standard Deviation 2.3
|
1.6 units on a scale
Standard Deviation 1.8
|
1.6 units on a scale
Standard Deviation 2.0
|
0.8 units on a scale
Standard Deviation 1.4
|
1.1 units on a scale
Standard Deviation 1.6
|
0.8 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Pain Scores (Visual Analogue Scale)
VAS rest at 48h postoperatively
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.3
|
0.4 units on a scale
Standard Deviation 0.9
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.3
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in Pain Scores (Visual Analogue Scale)
VAS cough at 6h postoperatively
|
4.7 units on a scale
Standard Deviation 2.7
|
4.2 units on a scale
Standard Deviation 2.0
|
4.7 units on a scale
Standard Deviation 2.7
|
3.9 units on a scale
Standard Deviation 1.9
|
3.9 units on a scale
Standard Deviation 1.9
|
2.7 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline in Pain Scores (Visual Analogue Scale)
VAS cough at 24h postoperatively
|
2.4 units on a scale
Standard Deviation 1.9
|
2.6 units on a scale
Standard Deviation 1.9
|
3.2 units on a scale
Standard Deviation 2.2
|
2.0 units on a scale
Standard Deviation 1.8
|
3.5 units on a scale
Standard Deviation 2.0
|
2.4 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Pain Scores (Visual Analogue Scale)
VAS cough at 48h postoperatively
|
1.3 units on a scale
Standard Deviation 1.5
|
2.4 units on a scale
Standard Deviation 1.7
|
2.3 units on a scale
Standard Deviation 2.3
|
1.3 units on a scale
Standard Deviation 1.4
|
1.4 units on a scale
Standard Deviation 1.8
|
0.8 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: up to 6 daysTime to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient
Outcome measures
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Time to Postoperative Bowel Recovery
|
56.6 hours
Standard Deviation 11.9
|
70.9 hours
Standard Deviation 11.9
|
67.1 hours
Standard Deviation 11.8
|
55.6 hours
Standard Deviation 12.7
|
58.6 hours
Standard Deviation 14.5
|
63.9 hours
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: up to 6 daysTime to being able to walk without assistance within the room or outside the room
Outcome measures
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Time to First Postoperative Ambulation
Walking in the room unassisted
|
19.0 hours
Standard Deviation 4.1
|
19.9 hours
Standard Deviation 3.4
|
19.1 hours
Standard Deviation 3.5
|
20.7 hours
Standard Deviation 4.6
|
21.4 hours
Standard Deviation 1.9
|
20.6 hours
Standard Deviation 3.3
|
|
Time to First Postoperative Ambulation
Walking out of the room unassisted
|
33.3 hours
Standard Deviation 12.1
|
47.0 hours
Standard Deviation 11.1
|
43.3 hours
Standard Deviation 11.1
|
39.5 hours
Standard Deviation 14.0
|
43.4 hours
Standard Deviation 11.6
|
45.1 hours
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: up to 48 hours postoperativelyCumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively
Outcome measures
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Consumption of Levobupivacaine at 24h and 48 h Postoperatively
Levobupivacaine consumption at 24h postoperatively
|
132.9 mg
Standard Deviation 58.9
|
178.8 mg
Standard Deviation 90.1
|
165.6 mg
Standard Deviation 92.9
|
325.7 mg
Standard Deviation 147.2
|
241.9 mg
Standard Deviation 145.0
|
203.1 mg
Standard Deviation 115.2
|
|
Consumption of Levobupivacaine at 24h and 48 h Postoperatively
Levobupivacaine consumption at 48h postoperatively
|
189.8 mg
Standard Deviation 117.5
|
240.9 mg
Standard Deviation 133.0
|
231.9 mg
Standard Deviation 139.2
|
435.4 mg
Standard Deviation 220.2
|
351.3 mg
Standard Deviation 193.6
|
294.7 mg
Standard Deviation 158.0
|
SECONDARY outcome
Timeframe: up to 48 hours postoperativelyCumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.
Outcome measures
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively
Epidural morphine consumption at 24h postoperative
|
4.8 mg
Standard Deviation 0.0
|
5.8 mg
Standard Deviation 0.0
|
6.8 mg
Standard Deviation 0.0
|
4.8 mg
Standard Deviation 0.0
|
5.8 mg
Standard Deviation 0.0
|
6.8 mg
Standard Deviation 0.0
|
|
Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively
Epidural morphine consumption at 48h postoperative
|
9.6 mg
Standard Deviation 0.0
|
10.6 mg
Standard Deviation 0.0
|
11.6 mg
Standard Deviation 0.0
|
9.6 mg
Standard Deviation 0.0
|
10.6 mg
Standard Deviation 0.0
|
11.6 mg
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: up to 6th day postoperativelyPreoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.
Outcome measures
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 Participants
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 Participants
Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 Participants
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 Participants
Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Change From Baseline of Spirometric Values
FVC at 12h postoperatively
|
63.2 percentage of preoperative values
Standard Deviation 15.2
|
69.3 percentage of preoperative values
Standard Deviation 13.1
|
68.3 percentage of preoperative values
Standard Deviation 15.9
|
71.7 percentage of preoperative values
Standard Deviation 14.0
|
66.4 percentage of preoperative values
Standard Deviation 11.3
|
66.8 percentage of preoperative values
Standard Deviation 14.6
|
|
Change From Baseline of Spirometric Values
FVC at 24h postoperatively
|
62.5 percentage of preoperative values
Standard Deviation 15.6
|
62.2 percentage of preoperative values
Standard Deviation 13.7
|
72.1 percentage of preoperative values
Standard Deviation 15.5
|
66.8 percentage of preoperative values
Standard Deviation 15.6
|
63.3 percentage of preoperative values
Standard Deviation 12.1
|
62.6 percentage of preoperative values
Standard Deviation 12.3
|
|
Change From Baseline of Spirometric Values
FVC at 36h postoperatively
|
65.7 percentage of preoperative values
Standard Deviation 13.6
|
61.2 percentage of preoperative values
Standard Deviation 13.8
|
65.2 percentage of preoperative values
Standard Deviation 15.5
|
63.9 percentage of preoperative values
Standard Deviation 13.4
|
62.8 percentage of preoperative values
Standard Deviation 14.6
|
63.2 percentage of preoperative values
Standard Deviation 9.3
|
|
Change From Baseline of Spirometric Values
FVC at 48h postoperatively
|
63.9 percentage of preoperative values
Standard Deviation 15.0
|
66.2 percentage of preoperative values
Standard Deviation 12.5
|
67.6 percentage of preoperative values
Standard Deviation 13.4
|
69.8 percentage of preoperative values
Standard Deviation 10.1
|
71.1 percentage of preoperative values
Standard Deviation 15.0
|
66.9 percentage of preoperative values
Standard Deviation 10.9
|
|
Change From Baseline of Spirometric Values
FVC at 72h postoperatively
|
69.4 percentage of preoperative values
Standard Deviation 7.0
|
71.3 percentage of preoperative values
Standard Deviation 11.8
|
76.2 percentage of preoperative values
Standard Deviation 16.8
|
72.4 percentage of preoperative values
Standard Deviation 10.9
|
77.3 percentage of preoperative values
Standard Deviation 15.1
|
76.7 percentage of preoperative values
Standard Deviation 9.0
|
|
Change From Baseline of Spirometric Values
FVC at 6th day postoperatively
|
79.0 percentage of preoperative values
Standard Deviation 18.3
|
83.9 percentage of preoperative values
Standard Deviation 7.6
|
83.1 percentage of preoperative values
Standard Deviation 8.0
|
84.0 percentage of preoperative values
Standard Deviation 11.5
|
80.0 percentage of preoperative values
Standard Deviation 18.2
|
89.2 percentage of preoperative values
Standard Deviation 9.6
|
|
Change From Baseline of Spirometric Values
FEV1 at 12h postoperatively
|
55.8 percentage of preoperative values
Standard Deviation 19.3
|
63.9 percentage of preoperative values
Standard Deviation 11.7
|
60.5 percentage of preoperative values
Standard Deviation 15.3
|
65.2 percentage of preoperative values
Standard Deviation 15.1
|
62.0 percentage of preoperative values
Standard Deviation 9.3
|
62.1 percentage of preoperative values
Standard Deviation 18.6
|
|
Change From Baseline of Spirometric Values
FEV1 at 24h postoperatively
|
61.5 percentage of preoperative values
Standard Deviation 17.1
|
55.2 percentage of preoperative values
Standard Deviation 18.4
|
71.0 percentage of preoperative values
Standard Deviation 15.0
|
63.8 percentage of preoperative values
Standard Deviation 16.4
|
56.4 percentage of preoperative values
Standard Deviation 14.8
|
59.8 percentage of preoperative values
Standard Deviation 12.1
|
|
Change From Baseline of Spirometric Values
FEV1 at 36h postoperatively
|
62.9 percentage of preoperative values
Standard Deviation 15.4
|
52.7 percentage of preoperative values
Standard Deviation 16.4
|
61.0 percentage of preoperative values
Standard Deviation 16.2
|
58.4 percentage of preoperative values
Standard Deviation 14.2
|
61.1 percentage of preoperative values
Standard Deviation 16.3
|
59.3 percentage of preoperative values
Standard Deviation 11.4
|
|
Change From Baseline of Spirometric Values
FEV1 at 48h postoperatively
|
64.9 percentage of preoperative values
Standard Deviation 18.1
|
55.9 percentage of preoperative values
Standard Deviation 22.5
|
68.2 percentage of preoperative values
Standard Deviation 19.6
|
61.8 percentage of preoperative values
Standard Deviation 8.8
|
67.1 percentage of preoperative values
Standard Deviation 12.6
|
64.9 percentage of preoperative values
Standard Deviation 11.6
|
|
Change From Baseline of Spirometric Values
FEV1 at 72h postoperatively
|
79.0 percentage of preoperative values
Standard Deviation 26.1
|
70.2 percentage of preoperative values
Standard Deviation 15.0
|
75.4 percentage of preoperative values
Standard Deviation 8.5
|
70.2 percentage of preoperative values
Standard Deviation 15.0
|
75.3 percentage of preoperative values
Standard Deviation 8.5
|
72.5 percentage of preoperative values
Standard Deviation 10.0
|
|
Change From Baseline of Spirometric Values
FEV1 at 6th day postoperatively
|
86.8 percentage of preoperative values
Standard Deviation 23.5
|
81.8 percentage of preoperative values
Standard Deviation 7.9
|
88.0 percentage of preoperative values
Standard Deviation 12.9
|
83.4 percentage of preoperative values
Standard Deviation 12.0
|
79.4 percentage of preoperative values
Standard Deviation 15.9
|
83.8 percentage of preoperative values
Standard Deviation 8.7
|
|
Change From Baseline of Spirometric Values
PEFR at 12h postoperatively
|
62.9 percentage of preoperative values
Standard Deviation 32.3
|
67.6 percentage of preoperative values
Standard Deviation 21.1
|
61.8 percentage of preoperative values
Standard Deviation 20.9
|
60.0 percentage of preoperative values
Standard Deviation 22.8
|
77.9 percentage of preoperative values
Standard Deviation 22.6
|
67.2 percentage of preoperative values
Standard Deviation 25.6
|
|
Change From Baseline of Spirometric Values
PEFR at 24h postoperatively
|
68.5 percentage of preoperative values
Standard Deviation 21.8
|
55.6 percentage of preoperative values
Standard Deviation 21.3
|
79.9 percentage of preoperative values
Standard Deviation 14.3
|
70.1 percentage of preoperative values
Standard Deviation 13.6
|
57.7 percentage of preoperative values
Standard Deviation 22.0
|
68.9 percentage of preoperative values
Standard Deviation 12.8
|
|
Change From Baseline of Spirometric Values
PEFR at 36h postoperatively
|
69.6 percentage of preoperative values
Standard Deviation 22.0
|
57.9 percentage of preoperative values
Standard Deviation 27.8
|
68.8 percentage of preoperative values
Standard Deviation 20.6
|
59.4 percentage of preoperative values
Standard Deviation 18.0
|
73.8 percentage of preoperative values
Standard Deviation 25.6
|
67.9 percentage of preoperative values
Standard Deviation 20.3
|
|
Change From Baseline of Spirometric Values
PEFR at 48h postoperatively
|
70.7 percentage of preoperative values
Standard Deviation 27.4
|
58.8 percentage of preoperative values
Standard Deviation 29.2
|
79.7 percentage of preoperative values
Standard Deviation 25.8
|
64.9 percentage of preoperative values
Standard Deviation 17.7
|
76.4 percentage of preoperative values
Standard Deviation 23.6
|
74.3 percentage of preoperative values
Standard Deviation 11.8
|
|
Change From Baseline of Spirometric Values
PEFR at 72h postoperatively
|
77.3 percentage of preoperative values
Standard Deviation 26.5
|
78.1 percentage of preoperative values
Standard Deviation 32.0
|
91.3 percentage of preoperative values
Standard Deviation 35.0
|
70.7 percentage of preoperative values
Standard Deviation 15.1
|
80.9 percentage of preoperative values
Standard Deviation 19.3
|
86.0 percentage of preoperative values
Standard Deviation 28.8
|
|
Change From Baseline of Spirometric Values
PEFR at 6th day postoperatively
|
93.8 percentage of preoperative values
Standard Deviation 31.5
|
98.4 percentage of preoperative values
Standard Deviation 34.6
|
96.4 percentage of preoperative values
Standard Deviation 15.3
|
76.3 percentage of preoperative values
Standard Deviation 16.1
|
83.7 percentage of preoperative values
Standard Deviation 20.5
|
89.6 percentage of preoperative values
Standard Deviation 19.5
|
Adverse Events
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 participants at risk
Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
n=16 participants at risk
Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
n=16 participants at risk
Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 participants at risk
Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
n=16 participants at risk
Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
n=16 participants at risk
Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Postoperative nausia and vomiting
|
0.00%
0/16 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
12.5%
2/16 • Number of events 2 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
6.2%
1/16 • Number of events 1 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
0.00%
0/16 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
6.2%
1/16 • Number of events 2 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
12.5%
2/16 • Number of events 2 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
|
Skin and subcutaneous tissue disorders
Postoperative pruritus
|
0.00%
0/16 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
12.5%
2/16 • Number of events 2 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
12.5%
2/16 • Number of events 2 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
0.00%
0/16 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
12.5%
2/16 • Number of events 2 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
6.2%
1/16 • Number of events 1 • Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Anastasia Zotou
University Hospital Of Patras, Greece
Phone: 0026130603341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place