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

NCT04212039 | Completed

• 1 other identifier: AUTFANESTHESIAHIP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Hip Dysplasia

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)

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

Drug: Bupivacaine

ultrasound guided sham block

SHAM COMPARATOR

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

Drug: Saline Solution

Interventions

Saline Solution DRUG

0.5 ml/kg saline

ultrasound guided sham block

Bupivacaine DRUG

0.5 ml/kg %0.25 bupivacaine

ultrasound guided pericapsular nerve group block

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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
• American Society of Anesthesiologist's III-IV

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (5)

• Aksu C, Cesur S, Kus A. Pericapsular nerve group (PENG) block for postoperative analgesia after open reduction of pediatric congenital dysplasia of the hip. J Clin Anesth. 2020 May;61:109675. doi: 10.1016/j.jclinane.2019.109675. Epub 2019 Dec 1. No abstract available.

  PMID: 31796372 BACKGROUND

• Ahiskalioglu A, Aydin ME, Celik M, Ahiskalioglu EO, Tulgar S. Can high volume pericapsular nerve group (PENG) block act as a lumbar plexus block? J Clin Anesth. 2020 May;61:109650. doi: 10.1016/j.jclinane.2019.109650. Epub 2019 Nov 12. No abstract available.

  PMID: 31732426 BACKGROUND

• Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.

  PMID: 31022606 BACKGROUND

• Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Tuncer K, Celik M. Pericapsular nerve group (PENG) block for surgical anesthesia of medial thigh. J Clin Anesth. 2020 Feb;59:42-43. doi: 10.1016/j.jclinane.2019.06.021. Epub 2019 Jun 15. No abstract available.

  PMID: 31212123 BACKGROUND

• Ahiskalioglu A, Aydin ME, Ozkaya F, Ahiskalioglu EO, Adanur S. A novel indication of Pericapsular Nerve Group (PENG) block: Prevention of adductor muscle spasm. J Clin Anesth. 2020 Mar;60:51-52. doi: 10.1016/j.jclinane.2019.08.034. Epub 2019 Aug 21. No abstract available.

  PMID: 31445179 BACKGROUND

MeSH Terms

Conditions

Hip Dislocation, Congenital

Interventions

Saline Solution; Bupivacaine

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: December 24, 2019
• First Posted: December 26, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

TU (1)