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Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02662660
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief Summary:
A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Port-sites infiltration:Bupivacaine0.25% Drug: Epidural analgesia:Levobupivacaine0,125% Drug: Metamizole and Acetaminophen iv Phase 3

Detailed Description:
A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Laparoscopic Sleeve Gastrectomy: Comparison of Isolated Intravenous Analgesia, Epidural Analgesia Associated With Analgesia iv and Port-sites Infiltration With Bupivacaine Associated With Analgesia iv
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Port-sites infiltration:Bupivacaine0,25%
Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
Drug: Port-sites infiltration:Bupivacaine0.25%
Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
Other Name: Port-sites infiltration with bupivacaine

Drug: Metamizole and Acetaminophen iv
Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
Other Name: Analgesia iv

Experimental: Epidural analgesia:Levobupivacaine0.125%

Epidural analgesia consists in the placement of a thoracic epidural catheter inserted at the level T6-T7 and administration of a continuous perfusion of Levobupivacaine 0.125% 6ml/h.

Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Drug: Epidural analgesia:Levobupivacaine0,125%
Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
Other Name: Epidural analgesia

Drug: Metamizole and Acetaminophen iv
Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
Other Name: Analgesia iv

Active Comparator: Metamizole and Acetaminophen iv
Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
Drug: Metamizole and Acetaminophen iv
Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
Other Name: Analgesia iv




Primary Outcome Measures :
  1. Postoperative pain measured by Visual Analogic Scale [ Time Frame: 24 hours after surgery ]
    Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery,



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • body mass index (BMI) >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria:

  • patients undergoing other bariatric techniques
  • severe underlying cardiovascular diseases
  • chronic renal failure
  • hepatic dysfunction
  • previous foregut surgery
  • patients with any contraindication for bariatric surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662660


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Manuel Duran, MD, PhD Hospital General Elche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02662660    
Other Study ID Numbers: HGUE 16-03
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Dipyrone
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents