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

NCT01249872 | Completed Phase 2 Results

• 1 other identifier: morbid obesity_post-op pain
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Scores (Visual Analogue Scale)

  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.

  up to 48 h postoperatively

Secondary Outcomes (5)

• Time to Postoperative Bowel Recovery

  up to 6 days

• Time to First Postoperative Ambulation

  up to 6 days

• Consumption of Levobupivacaine at 24h and 48 h Postoperatively

  up to 48 hours postoperatively

• Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively

  up to 48 hours postoperatively

• Change From Baseline of Spirometric Values

  up to 6th day postoperatively

Study Arms (6)

GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

ACTIVE COMPARATOR

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.

Drug: GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE

GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

ACTIVE COMPARATOR

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

Drug: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE

GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

ACTIVE COMPARATOR

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

Drug: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE

GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

ACTIVE COMPARATOR

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

Drug: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE

GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

ACTIVE COMPARATOR

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

Drug: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE

GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

ACTIVE COMPARATOR

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

Drug: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Interventions

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.

Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP A : 0 mg MORPHINE-0.1% 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.

Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP B : 1 mg MORPHINE- 0.1% 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.

Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP C : 2 mg MORPHINE-0.1% 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.

Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP D : 0 mg MORPHINE- 0.2% 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.

Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP E : 1 mg MORPHINE-0.2 % 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.

Also known as: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine

GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) \> 50
• Age \< 50
• Patients written consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

University of Patras, Department of Anesthesiology and Critical Care Medicine

Pátrai, Achaia, 26500, Greece

Location

MeSH Terms

Conditions

Obesity, Morbid; Pain, Postoperative

Interventions

Morphine; Levobupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

* Patients in groups A and D did not receive epidural morphine intraoperatively. * We excluded patients aged \> 50 yr as increasing the age of morbidly obese patients, might have increased the risk of perioperative complications

Results Point of Contact

• Title: Dr Anastasia Zotou
• Organization: University Hospital Of Patras, Greece

anzotou@hotmail.com

0026130603341

Study Officials

• KRITON S FILOS, MD, PhD, PROFESSOR

  Department of Anesthesiology and Critical Care

  STUDY CHAIR

• ATHINA SIAMPALIOTH, MD

  University Hospital of Patras

  STUDY DIRECTOR

• ANASTASIA ZOTOU, MD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist M.D, D.E.S.A.

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 30, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 24, 2013
• Results First Posted: July 24, 2013

Record last verified: 2013-06

Locations

GR (1)