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

• Sponsor: Ataturk University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04212039
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.4
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Hip Dysplasia	Drug: Saline Solution; Drug: Bupivacaine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 15, 2021

Arms and Interventions

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	Drug: Bupivacaine; 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	Drug: Saline Solution; 0.5 ml/kg saline

Outcome Measures

Primary Outcome Measures

1. Face, Legs, Activity, Cry and Consolability Score (FLACC) [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 Outcome Measures

1. Need for rescue analgesic [2 hour]

   Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour

2. Need for analgesic [24 hour]

   Number of patients who required analgesic in the first 24 hour

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University	Erzurum		Turkey	25100

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• Aksu C, Cesur S, Kuş 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.
• 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.

• Responsible Party: Ali Ahiskalioglu, Principal Investigator, Ataturk University
• ClinicalTrials.gov Identifier: NCT04212039
• Other Study ID Numbers: AUTFANESTHESIAHIP
• First Posted: Dec 26, 2019
• Last Update Posted: Jan 15, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Bupivacaine

Study Results

No Results Posted as of Jan 15, 2021