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

Congenital Hip Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212039
• Other study ID #: AUTFANESTHESIAHIP
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital

Intervention

Drug:
• Saline Solution
0.5 ml/kg saline
• Bupivacaine
0.5 ml/kg %0.25 bupivacaine

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Orozco S, Muñoz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for rescue analgesic	Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour	2 hour
Secondary	Need for analgesic	Number of patients who required analgesic in the first 24 hour	24 hour