Clinical trial NCT07023094: PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Official title: Comparison of Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block (LFCB) Versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB) in Pediatric Hip Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hip Disease
Hip Dysplasia
Hip Arthropathy
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Opioid Consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Time to first rescue opioid analgesia
timeFrame: 48 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 48 hours after surgery
measure: NLR
timeFrame: 12 hours after surgery
measure: NLR
timeFrame: 24 hours after surgery
measure: NLR
timeFrame: 48 hours after surgery
measure: PLR
timeFrame: 12 hours after surgery
measure: PLR
timeFrame: 24 hours after surgery
measure: PLR
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
Study officials:
affiliation: Poznan University of Medical Sciences
name: Malgorzata Reysner, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: