Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens
Condition: Morbid Obesity; Postoperative Pain; Postoperative Bowel Function; Postoperative Ambulation
MeSH terms: Obesity; Obesity, Morbid; Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): 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
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.; 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.; 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 intervention name(s): Morfina cloridrato 10 mg /ml - Morphine; Chirocaine 5 mg/ml - Levobupivacaine; Morfina cloridrato 10 mg /ml - Morphine; Chirocaine 5 mg/ml - Levobupivacaine; Morfina cloridrato 10 mg /ml - Morphine; Chirocaine 5 mg/ml - Levobupivacaine; Morfina cloridrato 10 mg /ml - Morphine; Chirocaine 5 mg/ml - Levobupivacaine; Morfina cloridrato 10 mg /ml - Morphine; Chirocaine 5 mg/ml - Levobupivacaine; Morfina cloridrato 10 mg /ml - Morphine; Chirocaine 5 mg/ml - Levobupivacaine
Intervention MeSH terms: Morphine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
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