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Completed

NCT Number: NCT06087549

PENG Block vs. ESP Block for Pediatric Hip Surgery

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

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Key information

Conditions

Hip Dysplasia Femoral Fractures Fractures, Bone Hip Disease Hip Dislocation Hip Fractures Hip Injuries Joint Diseases Joint Dislocations Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, 61-545, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pericapsular nerve group block using 0.2% ropivacaine

Drug

Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Erector Spinae Plane Block using 0.2% ropivacaine

Drug

Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Standard care

Other

No erector spinae block and no pericapsular nerve group block

Other names: No erector spinae block and no pericapsular nerve group block

Primary outcomes

  1. FLACC score

    Time frame: 48 hours after surgery

    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.

Secondary outcomes

  1. NLR

    Time frame: 48 hours after surgery

    neutrophil-to-lymphocyte ratio

  2. PLR

    Time frame: 48 hours after surgery

    platelet-to-lymphocyte ratio

  3. total opioid consumption

    Time frame: 48 hours after surgery

    morphine equivalents in miligrams

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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