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OpenTrials
Completed

NCT Number: NCT03949686

Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

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.

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Key information

Conditions

Congenital Hip Dysplasia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Hip Dislocation, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline Solution

Drug

0.5 ml/kg saline

Other names: saline

Bupivacaine

Drug

0.5 ml/kg %0.25 bupivacaine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 14, 2019
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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