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CompletedNCT01249872Updated Jul 24, 2013Results posted

Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens

A Phase 2/3 interventional study of GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE and GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE in Morbid Obesity, Postoperative Pain and Postoperative Bowel Function, sponsored by University of Patras. Completed at 1 site in Greece. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-07-24.

Sponsored by University of Patras · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has been studied, but up to date no data are available concerning the use of thoracic epidural patient-controlled analgesia regarding the use of levobupivacaine combined with morphine in morbidly obese patients. The investigators' aim in this prospective, randomized, double-blinded study was to compare the analgesic effectiveness, the dose requirements and side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine combined with a continuous epidural administration of morphine, with or without a loading dose, after open gastric bypass for morbid obesity.

Read the detailed description

Morbidly obese patients (BMI > 50 kg/m2) planned to undergo open variant of biliopancreatic diversion with Roux-en-Y gastric bypass (BPD-RYGBP) received standardized general anesthesia (intravenous propofol combined with remifentanyl and muscle relaxation). Preoperatively, in all patients an epidural catheter in the thoracic spine level will be placed between T5 and T8 interspace. All patients will be randomly allocated to six groups:

Group A patients will 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 patient controlled epidural anesthesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) , combined with a continuous epidural infusion of morphine 0.2 mg/h will be administered, Group B patients will receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery) and postoperatively the same levobupivacaine and morphine regimen as Group A, Group C patients will receive an epidural bolus dose 2 mg of morphine intra-operatively and thereafter the same levobupivacaine and morphine regimen as Group A.

Group D patients will receive intra-operatively an epidural bolus dose of 2 ml of normal saline. Postoperatively, the patients will receive PCEA in a dose of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h, Group E patients will receive intra-operatively an epidural bolus dose of 1mg of morphine intra-operatively and postoperatively the same regimen as Group D.

Group F patients will receive intra-operatively an epidural bolus dose of 2 mg of morphine intra-operatively and thereafter the same regimen as Group D.

Pain assessment will be performed using visual analogue scale (VAS, 10cm scale) at rest, at mobilization and at cough. Furthermore, total local anesthetic and morphine consumption, side effects on cardiovascular, respiratory and gastrointestinal systems, including blood pressure,blood gases, spirometric values Forced Expiratory Volume at 1 sec (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow Rate (PEFR), incidents of postoperative nausea and vomiting (PONV), pruritus, time to first flatus, postoperative ambulation will be recorded for up to 6 days.

02

Conditions studied

  • Morbid Obesity
  • Postoperative Pain
  • Postoperative Bowel Function
  • Postoperative Ambulation

Keywords

  • open gastric by-pass
  • super morbidly obese patients
  • postoperative thoracic epidural analgesia
  • different drug regimens (morphine and levobupivacaine)
  • Lung function tests
  • Postoperative Bowel recovery
  • Postoperative Ambulation
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 96 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Patras is the lead sponsor of 69 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body mass index (BMI) > 50
  • Age \< 50
  • Patients written consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Cardiovascular disease (valvular and ischemic heart disease)
  • Patients refusal to participate in the study
  • Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
  • Active psychiatric disease requiring treatment
  • Redo surgery
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Active comparator
    GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

    Group A patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Drug: GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

  • Active comparator
    GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

    Group B patients receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery). Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

    Drug: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

  • Active comparator
    GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

    Group C patients receive an epidural bolus dose 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

    Drug: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

  • Active comparator
    GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

    Group D patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline, epidurally. Postoperatively,patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

    Drug: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

  • Active comparator
    GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

    Group E patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

    Drug: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

  • Active comparator
    GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

    Group F patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 mg of morphine. Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

    Drug: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Interventions

  • DrugGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

    Patients 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) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

  • DrugGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

    Patients 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) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

  • DrugGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

    Patients receive intraoperatively (45 min before the estimated end of the surgery) a bolus dose 2 mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

  • DrugGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

    Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

  • DrugGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

    Patients 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) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

  • DrugGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

    Patients 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) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

    Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Pain Scores (Visual Analogue Scale)

    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.

    Time frame: up to 48 h postoperatively

Secondary outcomes

  1. Time to Postoperative Bowel Recovery

    Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient

    Time frame: up to 6 days

  2. Time to First Postoperative Ambulation

    Time to being able to walk without assistance within the room or outside the room

    Time frame: up to 6 days

  3. Consumption of Levobupivacaine at 24h and 48 h Postoperatively

    Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively

    Time frame: up to 48 hours postoperatively

  4. Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively

    Cumulative 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.

    Time frame: up to 48 hours postoperatively

  5. Change From Baseline of Spirometric Values

    Preoperatively, 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%.

    Time frame: up to 6th day postoperatively

07

Results

Posted Jul 24, 2013
Limitations and caveats
* Patients in groups A and D did not receive epidural morphine intraoperatively. * We excluded patients aged \> 50 yr as increasing the age of morbidly obese patients, might have increased the risk of perioperative complications

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)

Participant flow — Overall Study
MilestoneGROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Started161616161616
Completed161616161616
Not completed000000

Outcome measures

PrimaryChange From Baseline in Pain Scores (Visual Analogue Scale)

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.

Time frame:
up to 48 h postoperatively
Reported as:
Mean · units on a scale
Change From Baseline in Pain Scores (Visual Analogue Scale)
units on a scaleGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
VAS rest at 6h postoperatively1.4 ± 2.31.6 ± 1.81.6 ± 2.00.8 ± 1.41.1 ± 1.60.8 ± 1.2
VAS rest at 24h postoperatively0.1 ± 0.30.4 ± 0.90.4 ± 1.00.0 ± 0.01.8 ± 2.00.1 ± 0.5
VAS rest at 48h postoperatively0.0 ± 0.00.1 ± 0.30.4 ± 0.90.0 ± 0.00.1 ± 0.30.0 ± 0.0
VAS cough at 6h postoperatively4.7 ± 2.74.2 ± 2.04.7 ± 2.73.9 ± 1.93.9 ± 1.92.7 ± 2.2
VAS cough at 24h postoperatively2.4 ± 1.92.6 ± 1.93.2 ± 2.22.0 ± 1.83.5 ± 2.02.4 ± 1.9
VAS cough at 48h postoperatively1.3 ± 1.52.4 ± 1.72.3 ± 2.31.3 ± 1.41.4 ± 1.80.8 ± 1.2
SecondaryTime to Postoperative Bowel Recovery

Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient

Time frame:
up to 6 days
Reported as:
Mean · hours
Time to Postoperative Bowel Recovery
hoursGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Time to Postoperative Bowel Recovery56.6 ± 11.970.9 ± 11.967.1 ± 11.855.6 ± 12.758.6 ± 14.563.9 ± 12.0
SecondaryTime to First Postoperative Ambulation

Time to being able to walk without assistance within the room or outside the room

Time frame:
up to 6 days
Reported as:
Mean · hours
Time to First Postoperative Ambulation
hoursGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Walking in the room unassisted19.0 ± 4.119.9 ± 3.419.1 ± 3.520.7 ± 4.621.4 ± 1.920.6 ± 3.3
Walking out of the room unassisted33.3 ± 12.147.0 ± 11.143.3 ± 11.139.5 ± 14.043.4 ± 11.645.1 ± 10.7
SecondaryConsumption of Levobupivacaine at 24h and 48 h Postoperatively

Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively

Time frame:
up to 48 hours postoperatively
Reported as:
Mean · mg
Consumption of Levobupivacaine at 24h and 48 h Postoperatively
mgGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Levobupivacaine consumption at 24h postoperatively132.9 ± 58.9178.8 ± 90.1165.6 ± 92.9325.7 ± 147.2241.9 ± 145.0203.1 ± 115.2
Levobupivacaine consumption at 48h postoperatively189.8 ± 117.5240.9 ± 133.0231.9 ± 139.2435.4 ± 220.2351.3 ± 193.6294.7 ± 158.0
SecondaryCumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively

Cumulative 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.

Time frame:
up to 48 hours postoperatively
Reported as:
Mean · mg
Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively
mgGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Epidural morphine consumption at 24h postoperative4.8 ± 0.05.8 ± 0.06.8 ± 0.04.8 ± 0.05.8 ± 0.06.8 ± 0.0
Epidural morphine consumption at 48h postoperative9.6 ± 0.010.6 ± 0.011.6 ± 0.09.6 ± 0.010.6 ± 0.011.6 ± 0.0
SecondaryChange From Baseline of Spirometric Values

Preoperatively, 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%.

Time frame:
up to 6th day postoperatively
Reported as:
Mean · percentage of preoperative values
Change From Baseline of Spirometric Values
percentage of preoperative valuesGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
FVC at 12h postoperatively63.2 ± 15.269.3 ± 13.168.3 ± 15.971.7 ± 14.066.4 ± 11.366.8 ± 14.6
FVC at 24h postoperatively62.5 ± 15.662.2 ± 13.772.1 ± 15.566.8 ± 15.663.3 ± 12.162.6 ± 12.3
FVC at 36h postoperatively65.7 ± 13.661.2 ± 13.865.2 ± 15.563.9 ± 13.462.8 ± 14.663.2 ± 9.3
FVC at 48h postoperatively63.9 ± 15.066.2 ± 12.567.6 ± 13.469.8 ± 10.171.1 ± 15.066.9 ± 10.9
FVC at 72h postoperatively69.4 ± 7.071.3 ± 11.876.2 ± 16.872.4 ± 10.977.3 ± 15.176.7 ± 9.0
FVC at 6th day postoperatively79.0 ± 18.383.9 ± 7.683.1 ± 8.084.0 ± 11.580.0 ± 18.289.2 ± 9.6
FEV1 at 12h postoperatively55.8 ± 19.363.9 ± 11.760.5 ± 15.365.2 ± 15.162.0 ± 9.362.1 ± 18.6
FEV1 at 24h postoperatively61.5 ± 17.155.2 ± 18.471.0 ± 15.063.8 ± 16.456.4 ± 14.859.8 ± 12.1
FEV1 at 36h postoperatively62.9 ± 15.452.7 ± 16.461.0 ± 16.258.4 ± 14.261.1 ± 16.359.3 ± 11.4
FEV1 at 48h postoperatively64.9 ± 18.155.9 ± 22.568.2 ± 19.661.8 ± 8.867.1 ± 12.664.9 ± 11.6
FEV1 at 72h postoperatively79.0 ± 26.170.2 ± 15.075.4 ± 8.570.2 ± 15.075.3 ± 8.572.5 ± 10.0
FEV1 at 6th day postoperatively86.8 ± 23.581.8 ± 7.988.0 ± 12.983.4 ± 12.079.4 ± 15.983.8 ± 8.7
PEFR at 12h postoperatively62.9 ± 32.367.6 ± 21.161.8 ± 20.960.0 ± 22.877.9 ± 22.667.2 ± 25.6
PEFR at 24h postoperatively68.5 ± 21.855.6 ± 21.379.9 ± 14.370.1 ± 13.657.7 ± 22.068.9 ± 12.8
PEFR at 36h postoperatively69.6 ± 22.057.9 ± 27.868.8 ± 20.659.4 ± 18.073.8 ± 25.667.9 ± 20.3
PEFR at 48h postoperatively70.7 ± 27.458.8 ± 29.279.7 ± 25.864.9 ± 17.776.4 ± 23.674.3 ± 11.8
PEFR at 72h postoperatively77.3 ± 26.578.1 ± 32.091.3 ± 35.070.7 ± 15.180.9 ± 19.386.0 ± 28.8
PEFR at 6th day postoperatively93.8 ± 31.598.4 ± 34.696.4 ± 15.376.3 ± 16.183.7 ± 20.589.6 ± 19.5

Adverse events

Collected over Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE—0/16 (0%)0/16 (0%)
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE—3/16 (18.8%)0/16 (0%)
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE—3/16 (18.8%)0/16 (0%)
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE—0/16 (0%)0/16 (0%)
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE—2/16 (12.5%)0/16 (0%)
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE—3/16 (18.8%)0/16 (0%)
Most frequent serious events
Most frequent serious events
EventGROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Postoperative nausia and vomitingGastrointestinal disorders0/162/161/160/161/162/16
Postoperative pruritusSkin and subcutaneous tissue disorders0/162/162/160/162/161/16

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINETotal
<=18 years0000000
Between 18 and 65 years16161616161696
>=65 years0000000
Age Continuous
Age Continuous(years)GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINETotal
Age (yr)35.1 ± 9.432.8 ± 9.534.8 ± 9.234.3 ± 8.435.8 ± 8.135.1 ± 8.534.7 ± 7.3
Sex: Female, Male
Sex: Female, Male(Participants)GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINETotal
Female1012121012965
Male64464731
Region of Enrollment
Region of Enrollment(participants)GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINETotal
Greece16161616161696
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINETotal
Mean57.8 ± 5.657.5 ± 6.058.3 ± 7.858.6 ± 6.960.0 ± 3.959.4 ± 7.058.6 ± 6.2
08

Study locations

1 site
  • University of Patras, Department of Anesthesiology and Critical Care Medicine
    Patras, Achaia 26500, Greece
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01249872
Lead sponsor
University of Patras
Responsible party
Zotou Natassa,MD (Anesthesiologist M.D, D.E.S.A., University of Patras) — Principal investigator
First posted
Nov 30, 2010
Start date
Jan 2010
Primary completion
Aug 2012
Completion
Sep 2012
Results posted
Jul 24, 2013
Last update
Jul 24, 2013

Study contacts

KRITON S FILOS, MD, PhD, PROFESSOR
study chair · Department of Anesthesiology and Critical Care
ATHINA SIAMPALIOTH, MD
study director · University Hospital of Patras
ANASTASIA ZOTOU, MD
principal investigator · University Hospital of Patras

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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