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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zotou Natassa,MD, University of Patras
ClinicalTrials.gov Identifier:
NCT01249872
First received: November 22, 2010
Last updated: June 18, 2013
Last verified: June 2013
  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 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.


Condition Intervention Phase
Morbid Obesity
Postoperative Pain
Postoperative Bowel Function
Postoperative Ambulation
Drug: GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
Drug: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
Drug: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
Drug: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Drug: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
Drug: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
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: Postoperative Thoracic Epidural Analgesia in Super Obese Patients (~BMI 60 kg m-2) Undergoing Open Weight Loss Surgery :Does the Addition of Morphine to 0.1% and 0.2% Levobupivacaine Affect Postoperative Pain Relief, Perioperative Lung Function, Return of Normal Gastrointestinal Mobility and Ambulation?

Resource links provided by NLM:


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

  • Time to First Postoperative Ambulation [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    Time to being able to walk without assistance within the room or outside the room

  • Consumption of Levobupivacaine at 24h and 48 h Postoperatively [ Time Frame: up to 48 hours postoperatively ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 48 hours postoperatively ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 6th day postoperatively ] [ Designated as safety issue: Yes ]
    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%.


Enrollment: 96
Study Start Date: January 2010
Study Completion Date: September 2012
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% LEVOBUPIVACAINE
Group A patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
Drug: GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE
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.
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
Group B patients receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery). Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h
Drug: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE
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.
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
Group C patients receive an epidural bolus dose 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h
Drug: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
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.
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Group D patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline, epidurally. Postoperatively,patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h
Drug: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE
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.
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
Group E patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h
Drug: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
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.
Other Names:
  • Morfina cloridrato 10 mg /ml - Morphine
  • Chirocaine 5 mg/ml - Levobupivacaine
Active Comparator: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
Group F patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 mg of morphine. Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h
Drug: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE
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.
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 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.

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

Locations
Greece
University of Patras, Department of Anesthesiology and Critical Care Medicine
Patras, Achaia, Greece, 26500
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, D.E.S.A., 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
Results First Received: March 31, 2013
Last Updated: June 18, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
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

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

ClinicalTrials.gov processed this record on October 19, 2014