PENG Block vs. ESP Block for Pediatric Hip Surgery

NCT06087549 | Completed Phase 4

• 1 other identifier: 4/2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Dysplasia; Hip Injuries; Hip Fractures; Hip Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• NLR

  48 hours after surgery

• PLR

  48 hours after surgery

• total opioid consumption

  48 hours after surgery

Study Arms (3)

Control group

ACTIVE COMPARATOR

regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine

Other: Standard care

Pericapsular nerve group block (PENG) group

ACTIVE COMPARATOR

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

Erector Spinae Plane Block (ESPB) group

ACTIVE COMPARATOR

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

Interventions

Pericapsular nerve group block using 0.2% ropivacaine DRUG

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

Pericapsular nerve group block (PENG) group

Erector Spinae Plane Block using 0.2% ropivacaine DRUG

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

Erector Spinae Plane Block (ESPB) group

Standard care OTHER

No erector spinae block and no pericapsular nerve group block

Also known as: No erector spinae block and no pericapsular nerve group block

Control group

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- pediatric patients aged between 0-12 years who will undergo hip surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

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

Poznan, Wielkopolska, 61-545, Poland

Location

MeSH Terms

Conditions

Hip Dislocation; Hip Injuries; Hip Fractures

Interventions

Ropivacaine; Standard of Care

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Femoral Fractures; Fractures, Bone; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tomasz Kotwicki, Prof.dr hab

  Poznań University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly allocated to receive ultrasound-guided PENG block, ESP block, or only spinal anesthesia by computer software 1:1:1. A researcher who will not involve in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The patients and their anesthesia team, surgeon, operating room staff, and parents will be masked to the study group allocation. Group blinding unmasking will only occur once the statistical analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups: Group I -control Group II - PENG block Group III - ESP block

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: October 17, 2023
• Study Start: October 17, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

PL (1)