Clinical trial NCT01249872: Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Morbid Obesity
Postoperative Pain
Postoperative Bowel Function
Postoperative Ambulation
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
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Pain Scores (Visual Analogue Scale)
timeFrame: up to 48 h postoperatively
Secondary outcomes:
measure: Time to Postoperative Bowel Recovery
timeFrame: up to 6 days
measure: Time to First Postoperative Ambulation
timeFrame: up to 6 days
measure: Consumption of Levobupivacaine at 24h and 48 h Postoperatively
timeFrame: up to 48 hours postoperatively
measure: Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively
timeFrame: up to 48 hours postoperatively
measure: Change From Baseline of Spirometric Values
timeFrame: up to 6th day postoperatively
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University of Patras, Department of Anesthesiology and Critical Care Medicine
state: Achaia
Study officials:
affiliation: Department of Anesthesiology and Critical Care
name: KRITON S FILOS, MD, PhD, PROFESSOR
role: STUDY_CHAIR
affiliation: University Hospital of Patras
name: ATHINA SIAMPALIOTH, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Patras
name: ANASTASIA ZOTOU, MD
role: PRINCIPAL_INVESTIGATOR
References: