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NCT Number: NCT01249872

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

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.

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Key information

Conditions

Morbid Obesity Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Ambulation Postoperative Bowel Function Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Patras, Department of Anesthesiology and Critical Care Medicine

Pátrai, Achaia, 26500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

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.

Other names: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

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.

Other names: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

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.

Other names: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

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.

Other names: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

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.

Other names: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

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.

Other names: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

Primary outcomes

  1. Change From Baseline in Pain Scores (Visual Analogue Scale)

    Time frame: 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.

Secondary outcomes

  1. Time to Postoperative Bowel Recovery

    Time frame: up to 6 days

    Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient

  2. Time to First Postoperative Ambulation

    Time frame: up to 6 days

    Time to being able to walk without assistance within the room or outside the room

  3. Consumption of Levobupivacaine at 24h and 48 h Postoperatively

    Time frame: up to 48 hours postoperatively

    Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively

  4. Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively

    Time frame: up to 48 hours postoperatively

    Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.

  5. Change From Baseline of Spirometric Values

    Time frame: up to 6th day postoperatively

    Preoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study 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?

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2010
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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