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Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT03949686
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9.4
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. The aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) in pediatric patients undergoing CHD surgery.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Erector Spinae Plane Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study
Actual Study Start Date :
Apr 22, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Saline + Placebo

Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane

Drug: Saline Solution
0.5 ml/kg saline
Other Names:
  • saline

    		•
    Active Comparator: ultrasound guided erector spinae plane block

    Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane

    Drug: Bupivacaine
    0.5 ml/kg %0.25 bupivacaine

    Outcome Measures

    Primary Outcome Measures

    1. Face, Legs, Activity, Cry and Consolability Score (FLACC) [Postoperative first 24hour]

      FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    Secondary Outcome Measures

    1. Need for rescue analgesic [2 hour]

      Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour

    2. Need for analgesic [24 hour]

      Number of patients who required analgesic in the first 24 hour

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery
    Exclusion Criteria:

    • chronic pain

    • bleeding disorders

    • renal or hepatic insufficiency

    • patients on chronic non-steroidal anti-inflammatory medications

    • emergency cases

    • Incomplete patient forms

    • infection of the skin at the site of needle puncture area

    • patients with known allergies to any of the study drugs

    • ASA III-IV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ataturk University Erzurum Turkey 25100

    Sponsors and Collaborators

    • Ataturk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ali Ahiskalioglu, Principal Investigator, Ataturk University
    ClinicalTrials.gov Identifier:
    NCT03949686
    Other Study ID Numbers:
    • AUTF ANESTHESIA6
    First Posted:
    May 14, 2019
    Last Update Posted:
    Jul 22, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ali Ahiskalioglu, Principal Investigator, Ataturk University
    Postoperative Analgesia
    Ultrasound guided erector spinae plane block
    Additional relevant MeSH terms:
    Hip Dislocation
    Developmental Dysplasia of the Hip
    Hip Dislocation, Congenital
    Bupivacaine

    Study Results

    No Results Posted as of Jul 22, 2020