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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Active Comparator | 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. |
|
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Active Comparator | 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 |
|
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Active Comparator | 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 |
|
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Active Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 48 h postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Postoperative Bowel Recovery | Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient | up to 6 days |
| Time to First Postoperative Ambulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KRITON S FILOS, MD, PhD, PROFESSOR | Department of Anesthesiology and Critical Care | Study Chair |
| ATHINA SIAMPALIOTH, MD | University Hospital of Patras | Study Director |
| ANASTASIA ZOTOU, MD | University Hospital of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Patras, Department of Anesthesiology and Critical Care Medicine | Pátrai | Achaia | 26500 | Greece |
From the 107 patients, assessed for eligibility, 11 patients were excluded due to:
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Active Comparator | 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 |
|
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Active Comparator | 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 |
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|
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| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Drug | 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. |
|
|
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Drug | 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. |
|
|
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Drug | 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. |
|
|
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Drug | 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. |
|
|
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Drug | 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. |
|
|
Time to being able to walk without assistance within the room or outside the room
| up to 6 days |
| 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 | up to 48 hours postoperatively |
| 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. | up to 48 hours postoperatively |
| 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%. | up to 6th day postoperatively |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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%. | Posted | Mean | Standard Deviation | units on a scale | up to 48 h postoperatively |
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| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Postoperative Bowel Recovery | Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient | Posted | Mean | Standard Deviation | hours | up to 6 days |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Postoperative Ambulation | Time to being able to walk without assistance within the room or outside the room | Posted | Mean | Standard Deviation | hours | up to 6 days |
| |||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | mg | up to 48 hours postoperatively |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | mg | up to 48 hours postoperatively |
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| 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%. | Posted | Mean | Standard Deviation | percentage of preoperative values | up to 6th day postoperatively |
|
Adverse effects (opioid or epidural related) were assessed during the in hospital postoperative period (6days)
Clinical observation and reported by the patient
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 16 | 0 | 16 | ||
| EG001 | 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. | 3 | 16 | 0 | 16 | ||
| EG002 | 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. | 3 | 16 | 0 | 16 | ||
| EG003 | 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. | 0 | 16 | 0 | 16 | ||
| EG004 | 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. | 2 | 16 | 0 | 16 | ||
| EG005 | 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. | 3 | 16 | 0 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative nausia and vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Postoperative pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anastasia Zotou | University Hospital Of Patras, Greece | 0026130603341 | anzotou@hotmail.com |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| VAS rest at 24h postoperatively |
|
| VAS rest at 48h postoperatively |
|
| VAS cough at 6h postoperatively |
|
| VAS cough at 24h postoperatively |
|
| VAS cough at 48h postoperatively |
|
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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