Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Erector Spinae Plane Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study

Conditions
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Congenital Hip Dysplasia

Intervention / Treatment
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* Drug: Saline Solution
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Saline + Placebo<br>Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane | Drug: Saline Solution<br>* 0.5 ml/kg saline<br>* Other names: saline;|
| Active Comparator: ultrasound guided erector spinae plane block<br>Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane | Drug: Bupivacaine<br>* 0.5 ml/kg %0.25 bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face, Legs, Activity, Cry and Consolability Score (FLACC) | 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. | Postoperative first 24hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue analgesic | Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour | 2 hour | 
| Need for analgesic | Number of patients who required analgesic in the first 24 hour | 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Analgesia, Ultrasound guided erector spinae plane block