Morbid Obesity, Postoperative Ambulation, Postoperative Bowel Function, Postoperative Pain
Conditions
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
Brief 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.
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.
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.
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.
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.
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.
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.
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.
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) \> 50 * Age \< 50 * Patients written consent to participate in the study
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Scores (Visual Analogue Scale) | up to 48 h postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Postoperative Bowel Recovery | up to 6 days | Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient |
| Time to First Postoperative Ambulation | up to 6 days | Time to being able to walk without assistance within the room or outside the room |
| Consumption of Levobupivacaine at 24h and 48 h Postoperatively | up to 48 hours postoperatively | Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively |
| Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | up to 48 hours 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. |
| Change From Baseline of Spirometric Values | up to 6th day postoperatively | 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%. |
Countries
Greece
Participant flow
Recruitment details
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)
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 16 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE 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. | 16 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE 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. | 16 |
| 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) 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. | 16 |
| 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) 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. | 16 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE 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. | 16 |
| Total | 96 |
Baseline characteristics
| Characteristic | GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 16 Participants | 16 Participants | 16 Participants | 16 Participants | 96 Participants |
| Age Continuous Age (yr) | 35.1 years STANDARD_DEVIATION 9.4 | 32.8 years STANDARD_DEVIATION 9.5 | 34.8 years STANDARD_DEVIATION 9.2 | 34.3 years STANDARD_DEVIATION 8.4 | 35.8 years STANDARD_DEVIATION 8.1 | 35.1 years STANDARD_DEVIATION 8.5 | 34.7 years STANDARD_DEVIATION 7.3 |
| Body Mass Index (BMI) | 57.8 kg/m2 STANDARD_DEVIATION 5.6 | 57.5 kg/m2 STANDARD_DEVIATION 6 | 58.3 kg/m2 STANDARD_DEVIATION 7.8 | 58.6 kg/m2 STANDARD_DEVIATION 6.9 | 60.0 kg/m2 STANDARD_DEVIATION 3.9 | 59.4 kg/m2 STANDARD_DEVIATION 7 | 58.6 kg/m2 STANDARD_DEVIATION 6.2 |
| Region of Enrollment Greece | 16 participants | 16 participants | 16 participants | 16 participants | 16 participants | 16 participants | 96 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 12 Participants | 10 Participants | 12 Participants | 9 Participants | 65 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 7 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 3 / 16 | 3 / 16 | 0 / 16 | 2 / 16 | 3 / 16 |
Outcome results
Primary
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
Population: 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%.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 6h postoperatively | 1.4 units on a scale | Standard Deviation 2.3 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 24h postoperatively | 0.1 units on a scale | Standard Deviation 0.3 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 48h postoperatively | 0.0 units on a scale | Standard Deviation 0 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 6h postoperatively | 4.7 units on a scale | Standard Deviation 2.7 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 24h postoperatively | 2.4 units on a scale | Standard Deviation 1.9 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 48h postoperatively | 1.3 units on a scale | Standard Deviation 1.5 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 24h postoperatively | 0.4 units on a scale | Standard Deviation 0.9 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 6h postoperatively | 4.2 units on a scale | Standard Deviation 2 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 48h postoperatively | 2.4 units on a scale | Standard Deviation 1.7 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 6h postoperatively | 1.6 units on a scale | Standard Deviation 1.8 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 48h postoperatively | 0.1 units on a scale | Standard Deviation 0.3 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 24h postoperatively | 2.6 units on a scale | Standard Deviation 1.9 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 48h postoperatively | 2.3 units on a scale | Standard Deviation 2.3 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 24h postoperatively | 3.2 units on a scale | Standard Deviation 2.2 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 6h postoperatively | 4.7 units on a scale | Standard Deviation 2.7 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 48h postoperatively | 0.4 units on a scale | Standard Deviation 0.9 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 6h postoperatively | 1.6 units on a scale | Standard Deviation 2 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 24h postoperatively | 0.4 units on a scale | Standard Deviation 1 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 6h postoperatively | 3.9 units on a scale | Standard Deviation 1.9 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 24h postoperatively | 0.0 units on a scale | Standard Deviation 0 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 48h postoperatively | 0.0 units on a scale | Standard Deviation 0 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 48h postoperatively | 1.3 units on a scale | Standard Deviation 1.4 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 24h postoperatively | 2.0 units on a scale | Standard Deviation 1.8 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 6h postoperatively | 0.8 units on a scale | Standard Deviation 1.4 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 6h postoperatively | 1.1 units on a scale | Standard Deviation 1.6 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 24h postoperatively | 3.5 units on a scale | Standard Deviation 2 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 24h postoperatively | 1.8 units on a scale | Standard Deviation 2 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 48h postoperatively | 0.1 units on a scale | Standard Deviation 0.3 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 6h postoperatively | 3.9 units on a scale | Standard Deviation 1.9 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 48h postoperatively | 1.4 units on a scale | Standard Deviation 1.8 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 6h postoperatively | 2.7 units on a scale | Standard Deviation 2.2 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 48h postoperatively | 0.0 units on a scale | Standard Deviation 0 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 24h postoperatively | 2.4 units on a scale | Standard Deviation 1.9 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS cough at 48h postoperatively | 0.8 units on a scale | Standard Deviation 1.2 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 24h postoperatively | 0.1 units on a scale | Standard Deviation 0.5 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline in Pain Scores (Visual Analogue Scale) | VAS rest at 6h postoperatively | 0.8 units on a scale | Standard Deviation 1.2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 48h postoperatively | 63.9 percentage of preoperative values | Standard Deviation 15 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 72h postoperatively | 77.3 percentage of preoperative values | Standard Deviation 26.5 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 6th day postoperatively | 79.0 percentage of preoperative values | Standard Deviation 18.3 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 72h postoperatively | 69.4 percentage of preoperative values | Standard Deviation 7 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 48h postoperatively | 70.7 percentage of preoperative values | Standard Deviation 27.4 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 36h postoperatively | 69.6 percentage of preoperative values | Standard Deviation 22 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 24h postoperatively | 62.5 percentage of preoperative values | Standard Deviation 15.6 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 6th day postoperatively | 93.8 percentage of preoperative values | Standard Deviation 31.5 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 24h postoperatively | 68.5 percentage of preoperative values | Standard Deviation 21.8 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 12h postoperatively | 62.9 percentage of preoperative values | Standard Deviation 32.3 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 6th day postoperatively | 86.8 percentage of preoperative values | Standard Deviation 23.5 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 72h postoperatively | 79.0 percentage of preoperative values | Standard Deviation 26.1 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 36h postoperatively | 65.7 percentage of preoperative values | Standard Deviation 13.6 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 12h postoperatively | 63.2 percentage of preoperative values | Standard Deviation 15.2 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 48h postoperatively | 64.9 percentage of preoperative values | Standard Deviation 18.1 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 36h postoperatively | 62.9 percentage of preoperative values | Standard Deviation 15.4 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 24h postoperatively | 61.5 percentage of preoperative values | Standard Deviation 17.1 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 12h postoperatively | 55.8 percentage of preoperative values | Standard Deviation 19.3 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 36h postoperatively | 61.2 percentage of preoperative values | Standard Deviation 13.8 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 12h postoperatively | 69.3 percentage of preoperative values | Standard Deviation 13.1 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 24h postoperatively | 62.2 percentage of preoperative values | Standard Deviation 13.7 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 48h postoperatively | 66.2 percentage of preoperative values | Standard Deviation 12.5 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 72h postoperatively | 71.3 percentage of preoperative values | Standard Deviation 11.8 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 6th day postoperatively | 83.9 percentage of preoperative values | Standard Deviation 7.6 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 12h postoperatively | 63.9 percentage of preoperative values | Standard Deviation 11.7 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 24h postoperatively | 55.2 percentage of preoperative values | Standard Deviation 18.4 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 36h postoperatively | 52.7 percentage of preoperative values | Standard Deviation 16.4 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 48h postoperatively | 55.9 percentage of preoperative values | Standard Deviation 22.5 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 72h postoperatively | 70.2 percentage of preoperative values | Standard Deviation 15 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 6th day postoperatively | 81.8 percentage of preoperative values | Standard Deviation 7.9 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 12h postoperatively | 67.6 percentage of preoperative values | Standard Deviation 21.1 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 24h postoperatively | 55.6 percentage of preoperative values | Standard Deviation 21.3 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 36h postoperatively | 57.9 percentage of preoperative values | Standard Deviation 27.8 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 48h postoperatively | 58.8 percentage of preoperative values | Standard Deviation 29.2 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 72h postoperatively | 78.1 percentage of preoperative values | Standard Deviation 32 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 6th day postoperatively | 98.4 percentage of preoperative values | Standard Deviation 34.6 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 36h postoperatively | 65.2 percentage of preoperative values | Standard Deviation 15.5 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 48h postoperatively | 67.6 percentage of preoperative values | Standard Deviation 13.4 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 48h postoperatively | 68.2 percentage of preoperative values | Standard Deviation 19.6 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 72h postoperatively | 76.2 percentage of preoperative values | Standard Deviation 16.8 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 12h postoperatively | 68.3 percentage of preoperative values | Standard Deviation 15.9 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 6th day postoperatively | 88.0 percentage of preoperative values | Standard Deviation 12.9 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 72h postoperatively | 75.4 percentage of preoperative values | Standard Deviation 8.5 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 48h postoperatively | 79.7 percentage of preoperative values | Standard Deviation 25.8 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 24h postoperatively | 71.0 percentage of preoperative values | Standard Deviation 15 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 36h postoperatively | 68.8 percentage of preoperative values | Standard Deviation 20.6 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 6th day postoperatively | 96.4 percentage of preoperative values | Standard Deviation 15.3 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 24h postoperatively | 79.9 percentage of preoperative values | Standard Deviation 14.3 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 12h postoperatively | 60.5 percentage of preoperative values | Standard Deviation 15.3 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 72h postoperatively | 91.3 percentage of preoperative values | Standard Deviation 35 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 36h postoperatively | 61.0 percentage of preoperative values | Standard Deviation 16.2 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 6th day postoperatively | 83.1 percentage of preoperative values | Standard Deviation 8 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 24h postoperatively | 72.1 percentage of preoperative values | Standard Deviation 15.5 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 12h postoperatively | 61.8 percentage of preoperative values | Standard Deviation 20.9 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 24h postoperatively | 63.8 percentage of preoperative values | Standard Deviation 16.4 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 12h postoperatively | 71.7 percentage of preoperative values | Standard Deviation 14 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 12h postoperatively | 65.2 percentage of preoperative values | Standard Deviation 15.1 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 36h postoperatively | 63.9 percentage of preoperative values | Standard Deviation 13.4 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 36h postoperatively | 58.4 percentage of preoperative values | Standard Deviation 14.2 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 72h postoperatively | 70.7 percentage of preoperative values | Standard Deviation 15.1 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 48h postoperatively | 61.8 percentage of preoperative values | Standard Deviation 8.8 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 72h postoperatively | 70.2 percentage of preoperative values | Standard Deviation 15 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 6th day postoperatively | 83.4 percentage of preoperative values | Standard Deviation 12 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 24h postoperatively | 66.8 percentage of preoperative values | Standard Deviation 15.6 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 12h postoperatively | 60.0 percentage of preoperative values | Standard Deviation 22.8 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 24h postoperatively | 70.1 percentage of preoperative values | Standard Deviation 13.6 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 36h postoperatively | 59.4 percentage of preoperative values | Standard Deviation 18 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 6th day postoperatively | 76.3 percentage of preoperative values | Standard Deviation 16.1 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 48h postoperatively | 64.9 percentage of preoperative values | Standard Deviation 17.7 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 48h postoperatively | 69.8 percentage of preoperative values | Standard Deviation 10.1 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 72h postoperatively | 72.4 percentage of preoperative values | Standard Deviation 10.9 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 6th day postoperatively | 84.0 percentage of preoperative values | Standard Deviation 11.5 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 6th day postoperatively | 80.0 percentage of preoperative values | Standard Deviation 18.2 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 48h postoperatively | 67.1 percentage of preoperative values | Standard Deviation 12.6 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 72h postoperatively | 77.3 percentage of preoperative values | Standard Deviation 15.1 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 12h postoperatively | 77.9 percentage of preoperative values | Standard Deviation 22.6 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 36h postoperatively | 61.1 percentage of preoperative values | Standard Deviation 16.3 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 24h postoperatively | 57.7 percentage of preoperative values | Standard Deviation 22 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 24h postoperatively | 56.4 percentage of preoperative values | Standard Deviation 14.8 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 36h postoperatively | 73.8 percentage of preoperative values | Standard Deviation 25.6 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 12h postoperatively | 66.4 percentage of preoperative values | Standard Deviation 11.3 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 6th day postoperatively | 83.7 percentage of preoperative values | Standard Deviation 20.5 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 12h postoperatively | 62.0 percentage of preoperative values | Standard Deviation 9.3 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 48h postoperatively | 71.1 percentage of preoperative values | Standard Deviation 15 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 72h postoperatively | 80.9 percentage of preoperative values | Standard Deviation 19.3 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 48h postoperatively | 76.4 percentage of preoperative values | Standard Deviation 23.6 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 72h postoperatively | 75.3 percentage of preoperative values | Standard Deviation 8.5 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 24h postoperatively | 63.3 percentage of preoperative values | Standard Deviation 12.1 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 36h postoperatively | 62.8 percentage of preoperative values | Standard Deviation 14.6 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 6th day postoperatively | 79.4 percentage of preoperative values | Standard Deviation 15.9 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 24h postoperatively | 62.6 percentage of preoperative values | Standard Deviation 12.3 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 48h postoperatively | 74.3 percentage of preoperative values | Standard Deviation 11.8 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 36h postoperatively | 59.3 percentage of preoperative values | Standard Deviation 11.4 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 72h postoperatively | 86.0 percentage of preoperative values | Standard Deviation 28.8 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 48h postoperatively | 64.9 percentage of preoperative values | Standard Deviation 11.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 12h postoperatively | 67.2 percentage of preoperative values | Standard Deviation 25.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 72h postoperatively | 72.5 percentage of preoperative values | Standard Deviation 10 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 6th day postoperatively | 89.6 percentage of preoperative values | Standard Deviation 19.5 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 24h postoperatively | 59.8 percentage of preoperative values | Standard Deviation 12.1 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 72h postoperatively | 76.7 percentage of preoperative values | Standard Deviation 9 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 48h postoperatively | 66.9 percentage of preoperative values | Standard Deviation 10.9 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 24h postoperatively | 68.9 percentage of preoperative values | Standard Deviation 12.8 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 12h postoperatively | 66.8 percentage of preoperative values | Standard Deviation 14.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 6th day postoperatively | 89.2 percentage of preoperative values | Standard Deviation 9.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FVC at 36h postoperatively | 63.2 percentage of preoperative values | Standard Deviation 9.3 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 12h postoperatively | 62.1 percentage of preoperative values | Standard Deviation 18.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | FEV1 at 6th day postoperatively | 83.8 percentage of preoperative values | Standard Deviation 8.7 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Change From Baseline of Spirometric Values | PEFR at 36h postoperatively | 67.9 percentage of preoperative values | Standard Deviation 20.3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 48h postoperatively | 189.8 mg | Standard Deviation 117.5 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 24h postoperatively | 132.9 mg | Standard Deviation 58.9 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 24h postoperatively | 178.8 mg | Standard Deviation 90.1 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 48h postoperatively | 240.9 mg | Standard Deviation 133 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 24h postoperatively | 165.6 mg | Standard Deviation 92.9 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 48h postoperatively | 231.9 mg | Standard Deviation 139.2 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 48h postoperatively | 435.4 mg | Standard Deviation 220.2 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 24h postoperatively | 325.7 mg | Standard Deviation 147.2 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 24h postoperatively | 241.9 mg | Standard Deviation 145 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 48h postoperatively | 351.3 mg | Standard Deviation 193.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 48h postoperatively | 294.7 mg | Standard Deviation 158 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Consumption of Levobupivacaine at 24h and 48 h Postoperatively | Levobupivacaine consumption at 24h postoperatively | 203.1 mg | Standard Deviation 115.2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 24h postoperative | 4.8 mg | Standard Deviation 0 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 48h postoperative | 9.6 mg | Standard Deviation 0 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 24h postoperative | 5.8 mg | Standard Deviation 0 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 48h postoperative | 10.6 mg | Standard Deviation 0 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 24h postoperative | 6.8 mg | Standard Deviation 0 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 48h postoperative | 11.6 mg | Standard Deviation 0 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 24h postoperative | 4.8 mg | Standard Deviation 0 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 48h postoperative | 9.6 mg | Standard Deviation 0 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 24h postoperative | 5.8 mg | Standard Deviation 0 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 48h postoperative | 10.6 mg | Standard Deviation 0 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 24h postoperative | 6.8 mg | Standard Deviation 0 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively | Epidural morphine consumption at 48h postoperative | 11.6 mg | Standard Deviation 0 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking in the room unassisted | 19.0 hours | Standard Deviation 4.1 |
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking out of the room unassisted | 33.3 hours | Standard Deviation 12.1 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking in the room unassisted | 19.9 hours | Standard Deviation 3.4 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking out of the room unassisted | 47.0 hours | Standard Deviation 11.1 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking in the room unassisted | 19.1 hours | Standard Deviation 3.5 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking out of the room unassisted | 43.3 hours | Standard Deviation 11.1 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking in the room unassisted | 20.7 hours | Standard Deviation 4.6 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking out of the room unassisted | 39.5 hours | Standard Deviation 14 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking in the room unassisted | 21.4 hours | Standard Deviation 1.9 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking out of the room unassisted | 43.4 hours | Standard Deviation 11.6 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking in the room unassisted | 20.6 hours | Standard Deviation 3.3 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Time to First Postoperative Ambulation | Walking out of the room unassisted | 45.1 hours | Standard Deviation 10.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Time to Postoperative Bowel Recovery | 56.6 hours | Standard Deviation 11.9 |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Time to Postoperative Bowel Recovery | 70.9 hours | Standard Deviation 11.9 |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Time to Postoperative Bowel Recovery | 67.1 hours | Standard Deviation 11.8 |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Time to Postoperative Bowel Recovery | 55.6 hours | Standard Deviation 12.7 |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Time to Postoperative Bowel Recovery | 58.6 hours | Standard Deviation 14.5 |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Time to Postoperative Bowel Recovery | 63.9 hours | Standard Deviation 12 |