Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03949686

Enrollment

Registered

2019-05-14

Start date

2019-04-22

Completion date

2020-02-01

Last updated

2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hip Dysplasia

Keywords

Postoperative Analgesia, Ultrasound guided erector spinae plane block

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.

Interventions

DRUGSaline Solution

0.5 ml/kg saline

DRUGBupivacaine

0.5 ml/kg %0.25 bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026