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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Port-sites infiltration:Bupivacaine0.25%
Epidural analgesia:Levobupivacaine0,125%
Metamizole and Acetaminophen iv
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Port-sites infiltration:Bupivacaine0,25%

    Epidural analgesia:Levobupivacaine0.125%

    Metamizole and Acetaminophen iv

    Arm Description

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

    Postoperative pain measured by Visual Analogic Scale
    Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery,

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2016
    Last Updated
    January 20, 2016
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02662660
    Brief Title
    Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Port-sites infiltration:Bupivacaine0,25%
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Epidural analgesia:Levobupivacaine0.125%
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Metamizole and Acetaminophen iv
    Arm Type
    Active Comparator
    Arm Description
    Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Port-sites infiltration:Bupivacaine0.25%
    Other Intervention Name(s)
    Port-sites infiltration with bupivacaine
    Intervention Description
    Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
    Intervention Type
    Drug
    Intervention Name(s)
    Epidural analgesia:Levobupivacaine0,125%
    Other Intervention Name(s)
    Epidural analgesia
    Intervention Description
    Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
    Intervention Type
    Drug
    Intervention Name(s)
    Metamizole and Acetaminophen iv
    Other Intervention Name(s)
    Analgesia iv
    Intervention Description
    Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
    Primary Outcome Measure Information:
    Title
    Postoperative pain measured by Visual Analogic Scale
    Description
    Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery,
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manuel Duran, MD, PhD
    Organizational Affiliation
    Hospital General Elche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27177956
    Citation
    Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.
    Results Reference
    derived

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

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