NCT03949686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

May 9, 2019

Last Update Submit

July 21, 2020

Conditions

Congenital Hip Dysplasia

Keywords

Postoperative AnalgesiaUltrasound guided erector spinae plane block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Need for rescue analgesic

    2 hour

  • Need for analgesic

    24 hour

Study Arms (2)

Saline + Placebo

SHAM COMPARATOR

Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane

Drug: Saline Solution

ultrasound guided erector spinae plane block

ACTIVE COMPARATOR

Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane

Drug: Bupivacaine

Interventions

Saline SolutionDRUG

0.5 ml/kg saline

Also known as: saline
Saline + Placebo
BupivacaineDRUG

0.5 ml/kg %0.25 bupivacaine

ultrasound guided erector spinae plane block

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

  • Elkoundi A, Bentalha A, Kettani SEE, Mosadik A, Koraichi AE. Erector spinae plane block for pediatric hip surgery -a case report. Korean J Anesthesiol. 2019 Feb;72(1):68-71. doi: 10.4097/kja.d.18.00149. Epub 2018 Aug 24.

    PMID: 30139214BACKGROUND

  • Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.

    PMID: 30662115BACKGROUND

MeSH Terms

Conditions

Hip Dislocation, Congenital

Interventions

Saline SolutionSodium ChlorideBupivacaine

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the HipMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 14, 2019

Study Start

April 22, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)