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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Disease
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia
• Hip Fractures
• Hip Injuries

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