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Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paravertebral blockade
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I-II
  • Between the ages of 1-5 years
  • Forty children

Exclusion Criteria:

  • Refusals by parents
  • Children with spine deformities
  • Cutaneous infection
  • Bleeding diathesis
  • Allergy to drugs used
  • ASA physical status III-IV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Paravertebral blockade

    Paracetamol

    Arm Description

    Paravertebral blockade

    The patients was given 15 mg/kg of paracetamol.

    Outcomes

    Primary Outcome Measures

    Pain score

    Secondary Outcome Measures

    Full Information

    First Posted
    November 7, 2014
    Last Updated
    November 14, 2014
    Sponsor
    Cukurova University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02291692
    Brief Title
    Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children
    Official Title
    Ultrasound Guided Thoracic Paravertebral Block
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral block with bupivacaine on both perioperative anesthetic agent consumption and postoperative analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.
    Detailed Description
    This study was performed after approval of Ethics Committee and parents written consent. Between the ages 1-5, planned percutaneous nephrolithotomy due to kidney stones 40 patients were enrolled in this study, and patients were randomly divided into two group. All patients were performed general anaesthesia. The Group I patients was given ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5 after giving prone position and the Group II patients was given 15 mg/kg of paracetamol as postoperative analgesia. In the period of postoperative, if the FLACC > 4; it was planned to dose 1 mg/kg of tramadol. Patients' hemodynamic parameters, oxygen saturation, sevoflurane concentration were recorded 10, 15, 30 and 60 minutes intraoperatively. Patients' hemodynamic parameters, oxygen saturation, pain scores (FLACC), satisfaction of parents, the number of patients who additional analgesic requirements and side effects (nausea,vomiting, hypotension, bradycardia, respiration problems etc) were recorded in the postoperative period. Primary outcome measures was pain scores using FLACC scale.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paravertebral blockade
    Arm Type
    Active Comparator
    Arm Description
    Paravertebral blockade
    Arm Title
    Paracetamol
    Arm Type
    No Intervention
    Arm Description
    The patients was given 15 mg/kg of paracetamol.
    Intervention Type
    Procedure
    Intervention Name(s)
    paravertebral blockade
    Intervention Description
    ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5
    Primary Outcome Measure Information:
    Title
    Pain score
    Time Frame
    12 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA physical status I-II Between the ages of 1-5 years Forty children Exclusion Criteria: Refusals by parents Children with spine deformities Cutaneous infection Bleeding diathesis Allergy to drugs used ASA physical status III-IV
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gülşah Akıncı, MD
    Organizational Affiliation
    Cukurova University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18482238
    Citation
    Berta E, Spanhel J, Smakal O, Smolka V, Gabrhelik T, Lonnqvist PA. Single injection paravertebral block for renal surgery in children. Paediatr Anaesth. 2008 Jul;18(7):593-7. doi: 10.1111/j.1460-9592.2008.02592.x. Epub 2008 May 8.
    Results Reference
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    Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

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