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Clinical Trials/NCT07023094
NCT07023094RecruitingPhase 4

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

Poznan University of Medical Sciences1 site in 1 country60 target enrollmentStarted: June 16, 2025Last updated:
Interventions

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Total Opioid Consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

PENG + LFCB

Active Comparator

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

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

Intervention: Ropivacaine 0.2% for PENG Block (Drug)

PENG + LFCB

Active Comparator

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

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

Intervention: Ropivacaine 0.2% for LFCB (Drug)

L-ESPB + S-ESPB

Active Comparator

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

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

Intervention: Ropivacaine 0.2% for L-ESPB (Drug)

L-ESPB + S-ESPB

Active Comparator

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

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

Intervention: Ropivacaine 0.2% for S-ESPB (Drug)

Outcomes

Primary Outcomes

Total Opioid Consumption

Time Frame: 48 hours after surgery

Total opiate consumption after surgery

Secondary Outcomes

  • PLR(48 hours after surgery)
  • Time to first rescue opioid analgesia(48 hours after surgery)
  • Numerical Rating Scale [range 0:10](48 hours after surgery)
  • NLR(48 hours after surgery)

Investigators

Sponsor
Poznan University of Medical Sciences
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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