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NCT06087549 Clinical Trial

PENG Block vs. ESP Block for Pediatric Hip Surgery

Hip Fractures Clinical Trial

Official title:
PENG Block vs. ESP Block for Pediatric Hip Surgery. A Randomized, Prospective Double-blinded Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06087549
Other study ID # 4/2023
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 17, 2023
Est. completion date February 23, 2024

Study information
Verified date February 2024
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.

Description:

The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date February 23, 2024
Est. primary completion date February 23, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Months to 12 Years
Eligibility Inclusion Criteria: - pediatric patients aged between 0-12 years who will undergo hip surgery Exclusion Criteria: - a history of chronic pain use of gabapentin/pregabalin for > 3 months opioid use > 1 repeated opioid prescription in the last three months - morbid obesity (BMI > 99th percentile) - Infection at block application area - coagulopathy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pericapsular nerve group block using 0.2% ropivacaine
Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)
• Erector Spinae Plane Block using 0.2% ropivacaine
Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)
Other:
• Standard care
No erector spinae block and no pericapsular nerve group block

Locations
Country Name City State
Poland Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland Poznan Wielkopolska

Sponsors (1)
Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary FLACC score The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. 48 hours after surgery
Secondary NLR neutrophil-to-lymphocyte ratio 48 hours after surgery
Secondary PLR platelet-to-lymphocyte ratio 48 hours after surgery
Secondary total opioid consumption morphine equivalents in miligrams 48 hours after surgery
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