At a glance
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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?
In Brief
A Phase 3 clinical trial evaluating GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE, GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE, and 4 other interventions for Morbid Obesity and 3 related conditions. Completed, enrolled 96 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.