Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery

September 12, 2022 updated by: Ali Ahiskalioglu, Ataturk University

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

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 Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Erzurum, Turkey, 25100
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound guided pericapsular nerve group block
Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection between to iliopubic eminentia and psoas tendon
0.5 ml/kg %0.25 bupivacaine
Sham Comparator: ultrasound guided sham block
Ultrasound guided 0.5 ml/kg saline injection injection between to iliopubic eminentia and psoas tendon
0.5 ml/kg saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative first 24hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

December 24, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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