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Clinical Trials/NCT04212039
NCT04212039CompletedNot Applicable

Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study

Ataturk University1 site in 1 country48 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Face, Legs, Activity, Cry and Consolability Score (FLACC)

Study Overview

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. Pericapsular nerve group (PENG) block has been recently recommended for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve (AON) in the region between the anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE).The aim of this study was to evaluate the analgesic effect of ultrasound guided pediatric pericapsular nerve group (PENG) block in pediatric patients undergoing CHD surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
1 Year to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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
  • American Society of Anesthesiologist's III-IV

Arms & Interventions

ultrasound guided pericapsular nerve group block

Active Comparator

Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection between to iliopubic eminentia and psoas tendon

Intervention: Bupivacaine (Drug)

ultrasound guided sham block

Sham Comparator

Ultrasound guided 0.5 ml/kg saline injection injection between to iliopubic eminentia and psoas tendon

Intervention: Saline Solution (Drug)

Outcomes

Primary Outcomes

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

  • Need for rescue analgesic(2 hour)
  • Need for analgesic(24 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Ahiskalioglu

Principal Investigator

Ataturk University

Study Sites (1)

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