Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens
Information source: University of Patras
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Morbid Obesity; Postoperative Pain; Postoperative Bowel Function; Postoperative Ambulation
Intervention: 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 (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Patras Official(s) and/or principal investigator(s): KRITON S FILOS, MD, PhD, PROFESSOR, Study Chair, Affiliation: Department of Anesthesiology and Critical Care ATHINA SIAMPALIOTH, MD, Study Director, Affiliation: University Hospital of Patras ANASTASIA ZOTOU, MD, Principal Investigator, Affiliation: University Hospital of Patras
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.
Clinical Details
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?
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Pain Scores (Visual Analogue Scale)
Secondary outcome: Time to Postoperative Bowel RecoveryTime to First Postoperative Ambulation Consumption of Levobupivacaine at 24h and 48 h Postoperatively Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively Change From Baseline of Spirometric Values
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
University of Patras, Department of Anesthesiology and Critical Care Medicine, Patras, Achaia 26500, Greece
Additional Information
Starting date: January 2010
Last updated: June 18, 2013
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