PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery

NCT ID: NCT07023094

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2026-06-30

Brief Summary

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This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.

Detailed Description

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Orthopedic hip procedures in pediatric patients, including osteotomies, arthroscopic interventions, and reconstructive surgeries, often result in significant postoperative pain. Effective analgesia is critical for reducing surgical stress, accelerating rehabilitation, and minimizing opioid use and associated side effects. Regional anesthesia techniques have gained attention for their opioid-sparing effects and enhanced recovery profiles.

This randomized controlled trial aims to compare the analgesic effectiveness of two regional anesthetic approaches:

\- The pericapsular nerve group (PENG) block is combined with the lateral fetal cutaneous nerve block (LFCB), targeting hip joint innervation directly and providing comprehensive sensory coverage.

Lumbar and sacral erector spinae plane blocks (L-ESPB and S-ESPB) employ fascial plane techniques to deliver analgesia by diffusing local anesthetic around nerves innervating the hip region.

This trial aims to establish the optimal regional anesthesia technique and determine the clinical benefits of using dexamethasone and dexmedetomidine as adjuvants. The results will guide clinicians toward evidence-based analgesic protocols in pediatric orthopedic hip surgery, potentially reducing opioid-related complications and improving patient recovery outcomes.

Conditions

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Hip Disease Hip Dysplasia Hip Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PENG + LFCB

U-S guided PENG block - 0.4ml/kg 0.2% ropivacaine

\+ U-S guided LFCB - 0.1ml/kg 0.2% ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% for PENG Block

Intervention Type DRUG

U-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine

Ropivacaine 0.2% for LFCB

Intervention Type DRUG

LFCB (0.1 mL/kg) with 0.2% ropivacaine

L-ESPB + S-ESPB

U-S guided L-ESPB - 0.25ml/kg 0.2% ropivacaine

\+ U-S guided S-ESPB - 0.25ml/kg 0.2% ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% for L-ESPB

Intervention Type DRUG

Lumbar ESPB (0.25ml/kg) with 0.2% ropivacaine

Ropivacaine 0.2% for S-ESPB

Intervention Type DRUG

Sacral ESPB (0.25ml/kg) with 0.2% ropivacaine

Interventions

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Ropivacaine 0.2% for PENG Block

U-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine

Intervention Type DRUG

Ropivacaine 0.2% for LFCB

LFCB (0.1 mL/kg) with 0.2% ropivacaine

Intervention Type DRUG

Ropivacaine 0.2% for L-ESPB

Lumbar ESPB (0.25ml/kg) with 0.2% ropivacaine

Intervention Type DRUG

Ropivacaine 0.2% for S-ESPB

Sacral ESPB (0.25ml/kg) with 0.2% ropivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients aged between 2 and 16 years.
* Scheduled for elective orthopedic hip surgery, including: Osteotomies and Hip reconstruction surgeries
* ASA (American Society of Anesthesiologists) physical status classification: I-III.
* Written informed consent obtained from the patient's legal guardian(s).

Exclusion Criteria

* Known allergy or hypersensitivity to any of the study medications
* Presence of infection or inflammation at the intended injection site(s) of regional anesthesia.
* Coagulopathy or bleeding disorders (including patients on anticoagulant therapy) that contraindicate nerve blocks.
* Neurological disorders or peripheral neuropathies that could influence sensory or motor assessment of the lower limbs.
* Cognitive impairment or behavioral disorders significantly affecting pain assessment accuracy or cooperation.
* History of chronic opioid use or known substance abuse.
* Severe systemic disease or condition compromising patient safety or interfering with study protocol adherence.
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malgorzata Reysner, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Medical Sciences

Locations

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Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Malgorzata Reysner

Role: CONTACT

+48 61 873 83 03

Facility Contacts

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Malgorzata Reysner, MD. Ph.D.

Role: primary

+608762068

Other Identifiers

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6/2025

Identifier Type: -

Identifier Source: org_study_id

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