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Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

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: NCT03949686
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Ahiskalioglu, Ataturk University

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
Congenital Hip Dysplasia Drug: Saline Solution Drug: Bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 22, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Face, Legs, Activity, Cry and Consolability Score (FLACC) [ Time Frame: 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 [ Time Frame: 2 hour ]
    Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour

  2. Need for analgesic [ Time Frame: 24 hour ]
    Number of patients who required analgesic in the first 24 hour



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03949686


Locations
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Turkey
Ataturk University
Erzurum, Turkey, 25100
Sponsors and Collaborators
Ataturk University
Publications:
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Responsible Party: Ali Ahiskalioglu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier: NCT03949686    
Other Study ID Numbers: AUTF ANESTHESIA6
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Ahiskalioglu, Ataturk University:
Postoperative Analgesia
Ultrasound guided erector spinae plane block
Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents