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?

NCT01249872 Phase 2/Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	University of Patras
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	96
Start date	2010-01
Completion	2012-09

Conditions

• Morbid Obesity
• Postoperative Pain
• Postoperative Bowel Function
• Postoperative Ambulation

Interventions

• 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

Primary outcomes

• Change From Baseline in Pain Scores (Visual Analogue Scale) — up to 48 h postoperatively
  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.

Countries

Greece