PENG Block vs. ESP Block for Pediatric Hip Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Hip Injuries; Hip Dysplasia; Hip Disease
• Intervention / Treatment: Other: Standard care; Drug: Pericapsular nerve group block using 0.2% ropivacaine; Drug: Erector Spinae Plane Block using 0.2% ropivacaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-545
      • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine	Other: Standard care; No erector spinae block and no pericapsular nerve group block; Other Names: No erector spinae block and no pericapsular nerve group block
Active Comparator: Pericapsular nerve group block (PENG) group; regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL	Drug: Pericapsular nerve group block using 0.2% ropivacaine; Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)
Active Comparator: Erector Spinae Plane Block (ESPB) group; regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL	Drug: Erector Spinae Plane Block using 0.2% ropivacaine; Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NLR	neutrophil-to-lymphocyte ratio	48 hours after surgery
PLR	platelet-to-lymphocyte ratio	48 hours after surgery
total opioid consumption	morphine equivalents in miligrams	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Tomasz Kotwicki, Prof.dr hab, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Femoral Fractures; Musculoskeletal Abnormalities; Joint Dislocations; Hip Fractures; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Hip Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 4/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No