- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212039
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
Conditions
Intervention / Treatment
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.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Wounds and Injuries
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Hip Injuries
- Musculoskeletal Abnormalities
- Joint Dislocations
- Hip Dislocation
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- AUTFANESTHESIAHIP
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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