Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

Not Applicable

Completed

• Conditions: Congenital Hip Dysplasia
• Interventions: Drug: Saline Solution; Drug: Bupivacaine

• Registration Number: NCT03949686
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-12
• Study First Posted: 2019-05-14
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline + Placebo	Saline Solution	Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane
ultrasound guided erector spinae plane block	Bupivacaine	Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Need for analgesic	24 hour	Number of patients who required analgesic in the first 24 hour
Need for rescue analgesic	2 hour	Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey