Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens

NCT ID: NCT01249872

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Morbid Obesity; Postoperative Pain; Postoperative Bowel Function; Postoperative Ambulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

Group A patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.

Group Type: ACTIVE_COMPARATOR

GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

Intervention Type: DRUG

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.

GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

Group B patients receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery). Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

Group Type: ACTIVE_COMPARATOR

GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

Intervention Type: DRUG

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.

GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

Group C patients receive an epidural bolus dose 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

Group Type: ACTIVE_COMPARATOR

GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

Intervention Type: DRUG

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.

GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Group D patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline, epidurally. Postoperatively,patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

Group Type: ACTIVE_COMPARATOR

GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Intervention Type: DRUG

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.

GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

Group E patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

Group Type: ACTIVE_COMPARATOR

GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

Intervention Type: DRUG

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.

GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Group F patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 mg of morphine. Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h

Group Type: ACTIVE_COMPARATOR

GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Intervention Type: DRUG

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.

Interventions

GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

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.

Intervention Type: DRUG

GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

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.

Intervention Type: DRUG

GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

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.

Intervention Type: DRUG

GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

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.

Intervention Type: DRUG

GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

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.

Intervention Type: DRUG

GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

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.

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Zotou Natassa,MD

Anesthesiologist M.D, D.E.S.A.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KRITON S FILOS, MD, PhD, PROFESSOR

Role: STUDY_CHAIR

Department of Anesthesiology and Critical Care

ATHINA SIAMPALIOTH, MD

Role: STUDY_DIRECTOR

University Hospital of Patras

ANASTASIA ZOTOU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Locations

University of Patras, Department of Anesthesiology and Critical Care Medicine

Pátrai, Achaia, Greece

Countries

Greece

Other Identifiers

morbid obesity_post-op pain

Identifier Type: -

Identifier Source: org_study_id