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

This study is currently recruiting participants.
Verified April 2012 by University of Patras
Sponsor:
Information provided by (Responsible Party):
Zotou Natassa,MD, University of Patras
ClinicalTrials.gov Identifier:
NCT01249872
First received: November 22, 2010
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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 infusion of bolus doses of 0,1% and 0,2% levobupivacaine combined with a continuous administration of morphine, after open gastric bypass for morbid obesity.


Condition Intervention Phase
Morbid Obesity
Postoperative Pain
 Drug: EPIDURAL 0 mgMORPHINE- 0,1%CHIROCAINE
Drug: EPIDURAL 1 mg MORPHINE- 0,1% CHIROCAINE
Drug: EPIDURAL 2 mg MORPHINE - 0,1%CHIROCAINE
Drug: EPIDURAL 0mg MORPHINE - 0,2% CHIROCAINE
Drug: EPIDURAL 1 mg MORPHINE - 0,2% CHIROCAINE
Drug: EPIDURAL 2 mg MORPHINE-0,2% CHIROCAINE
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patients-Controlled Thoracic Epidural Analgesia After Gastric Bypass for Morbid Obesity: Comparison of 0,1% and 0,2% Levobupivacaine - Morphine Mixtures for Postoperative Pain Relief and Effects on Perioperative Lung Function

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Change from baseline in pain scores (Visual Analogue Scale) [ Time Frame: up to 48 hours ] [ Designated as safety issue: Yes ]
    Pain scores using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain)at 5, 30, 45 minutes and 1, 2, 4, 6, 12, 24, 36, 48 hours postoperatively


Secondary Outcome Measures:
  • Change from baseline of Spirometric values [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    Spirometric values (FVC, FEV1, FEV1/FVC, MEF50, MER25-75, PEF)at 4, 6, 12, 24, 36, 48, 72, 96, 144 hours postoperatively

  • Bowel recovery [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    Recovery of bowel function assessed by first flatus or stool, noticed by the patient

  • Change from baseline of hemodynamics profile [ Time Frame: up to 48 hours ] [ Designated as safety issue: Yes ]
    Measurement of arterial pressure (mmHg), heart rate (bpm)at 5, 30, 45 minutes and 1, 2, 4, 6, 12, 24, 36, 48 hours postoperatively


Estimated Enrollment: 96
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GROUP A : 0 mg MORPHINE-0,1% CHIRO
Group A patients will receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, immediately after extubation patient controlled epidural anesthesia (PCEA) using a continuous epidural infusion of morphine 0,2 mg/h, combined with 0,1% levobupivacaine (5ml, lockout interval 10min) will be administered
 Drug: EPIDURAL 0 mgMORPHINE- 0,1%CHIROCAINE
Patients will receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, immediately after extubation patient controlled epidural anesthesia (PCEA) using a continuous epidural infusion of morphine 0,2 mg/h, combined with 0,1% levobupivacaine (5ml, lockout interval 10min) will be administered
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP B : 1 mg MORPHINE- 0,1% CHIROCAINE
Group B patients will receive a 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
 Drug: EPIDURAL 1 mg MORPHINE- 0,1% CHIROCAINE
Patients will receive intraoperatively a bolus dose of 1mg of morphine (45 min before the estimated end of the surgery) and postoperatively,immediately after extubation patient controlled epidural anesthesia (PCEA) using a continuous epidural infusion of morphine 0,2 mg/h, combined with 0,1% levobupivacaine (5ml, lockout interval 10min) will be administered
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP C : 2 mg MORPHINE-0,1% CHIROCAINE
Group C patients will receive a bolus dose 2 mg of morphine intra-operatively and thereafter the same levobupivacaine and morphine regimen as Group A
 Drug: EPIDURAL 2 mg MORPHINE - 0,1%CHIROCAINE
Patients will receive intraoperatively a bolus dose 2 mg of morphine and postoperatively, immediately after extubation patient controlled epidural anesthesia (PCEA) using a continuous epidural infusion of morphine 0,2 mg/h, combined with 0,1% levobupivacaine (5ml, lockout interval 10min) will be administered
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP D : 0 mg MORPHINE- 0,2% CHIROCAINE
Group D patients will receive intra-operatively a 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
 Drug: EPIDURAL 0mg MORPHINE - 0,2% CHIROCAINE
Patients will receive intra-operatively a 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
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP E : 1 mg MORPHINE-0,2 % CHIROCAINE
Group E patients will receive intra-operatively a bolus dose of 1mg of morphine intra-operatively and postoperatively the same regimen as Group D.
 Drug: EPIDURAL 1 mg MORPHINE - 0,2% CHIROCAINE
Patients will receive intra-operatively a bolus dose of 1mg of morphine and postoperatively PCEA in a dose of 0,2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0,2 mg/h
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP F : 2 mg MORPHINE- 0,2% CHIROCAINE
Group F patients will receive intra-operatively a bolus dose of 2 mg of morphine intra-operatively and thereafter the same regimen as Group D
 Drug: EPIDURAL 2 mg MORPHINE-0,2% CHIROCAINE
Patients will receive a bolus dose of 2 mg of morphine intra-operatively and postoperatively PCEA in a dose of 0,2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0,2 mg/h
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine

Detailed Description:

Morbidly obese patients (BMI > 50 kg/m2) planned to undergo open Bili pancreatic diversion with R-en-Y gastric bypass (BPD R-en-Y gastric bypass ) or Bili pancreatic diversion (BPD) procedure, will be managed with standardized general anesthesia (intravenous Propofol combined with fentanyl and muscle relaxation). Preoperatively, in all patients an epidural catheter in the thoracic spine level will be placed between T5 and T8. All patients will be randomly allocated to six groups:

Group A patients (control group) will receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, immediately after extubation patient controlled epidural anesthesia (PCEA) using a continuous epidural infusion of morphine 0,2 mg/h, combined with 0,1% levobupivacaine (5ml, lockout interval 10min) will be administered, Group B patients will receive a 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 a 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 a 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 a bolus dose of 1mg of morphine intra-operatively and postoperatively the same regimen as Group D.

Group F patients will receive intra-operatively a 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 pressures, blood gases, spirometric values (FEV1, FVC, FEV1/FVC), incidents of PONV, prutitus, time to first flatus, motor blockage and length of hospital stay will be recorded for the first postoperative 48h.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249872

Contacts
Contact: ANASTASIA ZOTOU, MD 00302610620338 anzotou@hotmail.com

Locations
Greece
University of Patras, Department of Anesthesiology and Critical Care Medicine Recruiting
Patras, Achaia, Greece, 26500
Contact: KRITON S FILOS, MD, PhD     00302613603341     kritonfilos@yahoo.gr    
Sponsors and Collaborators
University of Patras
Investigators
Study Chair: KRITON S FILOS, MD, PhD, PROFESSOR Department of Anesthesiology and Critical Care
Study Director: ATHINA SIAMPALIOTH, MD University Hospital of Patras
Principal Investigator: ANASTASIA ZOTOU, MD University Hospital of Patras
  More Information

No publications provided

Responsible Party: Zotou Natassa,MD, Anesthesiologist M.D, University of Patras
ClinicalTrials.gov Identifier: NCT01249872     History of Changes
Other Study ID Numbers: morbid obesity_post-op pain
Study First Received: November 22, 2010
Last Updated: April 19, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
open gastric by-pass
different drug regimens
Lung function tests
Bowel function

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Pain, Postoperative
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Morphine
Levobupivacaine
 Bupivacaine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on May 22, 2013