Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2020-02-01

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.

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Detailed Description

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Conditions

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Congenital Hip Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Saline + Placebo

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

Group Type SHAM_COMPARATOR

Saline Solution

Intervention Type DRUG

0.5 ml/kg saline

ultrasound guided erector spinae plane block

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.5 ml/kg %0.25 bupivacaine

Interventions

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Saline Solution

0.5 ml/kg saline

Intervention Type DRUG

Bupivacaine

0.5 ml/kg %0.25 bupivacaine

Intervention Type DRUG

Other Intervention Names

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saline

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No