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TAP Block With Two Different Doses of Levobupivacaine

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levobupivacaine
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia
  • Aged between 2 and 12

Exclusion Criteria:

  • Patients with coagulation dysfunction
  • Patients with chronic pain
  • Patients having infection at the site of intervention
  • Patients with a history of allergy
  • Patients having chronic diseases (hepatic dysfunction, renal failure)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group Levobupivacaine high volume

    Group Levobupivacaine low volume

    Arm Description

    TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia

    TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia

    Outcomes

    Primary Outcome Measures

    postoperative VAS score <4 at postoperative 24 hours

    Secondary Outcome Measures

    Full Information

    First Posted
    September 17, 2015
    Last Updated
    October 2, 2015
    Sponsor
    Ankara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02567487
    Brief Title
    TAP Block With Two Different Doses of Levobupivacaine
    Official Title
    Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery. The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.
    Detailed Description
    Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Levobupivacaine high volume
    Arm Type
    Active Comparator
    Arm Description
    TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia
    Arm Title
    Group Levobupivacaine low volume
    Arm Type
    Active Comparator
    Arm Description
    TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine
    Other Intervention Name(s)
    Chirocaine
    Intervention Description
    Transversus abdominis plane block with levobupivacaine
    Primary Outcome Measure Information:
    Title
    postoperative VAS score <4 at postoperative 24 hours
    Time Frame
    Postoperative first 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia Aged between 2 and 12 Exclusion Criteria: Patients with coagulation dysfunction Patients with chronic pain Patients having infection at the site of intervention Patients with a history of allergy Patients having chronic diseases (hepatic dysfunction, renal failure)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neslihan Alkis
    Organizational Affiliation
    Ankara University Medical Faculty
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    TAP Block With Two Different Doses of Levobupivacaine

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