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Recruiting NCT07284615

Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

No phase Interventional Arthropathy of Hip Hip Arthropathy Locoregional Anesthesia Complication of Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PENG plus LFCN block, PENG plus WI.
Who it may be relevant to
Registry conditions: Arthropathy of Hip, Hip Arthropathy, Locoregional Anesthesia, Complication of Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration (WI) Combined With Pericapsular Nerve Group (PENG) Block for Analgesia in Elective Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

Overview

This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI). The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events. All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.

Interventions

  • Procedure PENG plus LFCN block
    The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.
  • Procedure PENG plus WI
    The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision

Primary outcome measures

  • Pain at rest control at 6h [Time frame: six hours after performing the regional anesthesia technique]
Secondary outcome measures (12)
  • Pain at rest control at 24h [Time frame: 24 hours after performing the regional anesthesia technique]
  • Pain at rest control at 48h [Time frame: 48 hours after performing the regional anesthesia technique]
  • Pain on movement control at 6h [Time frame: six hours after performing the regional anesthesia technique]
  • Pain on movement control at 24h [Time frame: 24 hours after performing the regional anesthesia technique]
  • Pain on movement control at 48h [Time frame: 48 hours after performing the regional anesthesia technique]
  • MRC at 6h [Time frame: six hours after performing the regional anesthesia technique]
  • MRC at 24h [Time frame: 24 hours after performing the regional anesthesia technique]
  • MRC at 48h [Time frame: 48 hours after performing the regional anesthesia technique]
  • time to first PRN opioid request [Time frame: Time Frame: From date of surgery until up to 48 hours after]
  • MME of PRN opioid total doses [Time frame: From date of surgery until up to 48 hours after]
  • Complication [Time frame: From date of surgery until up to 48 hours after]
  • the degree of hip flexion at 6h [Time frame: six hours after performing the regional anesthesia technique]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Elective total hip arthroplasty
  • Spinal (subarachnoid) anesthesia
  • Written informed consent provided by the patient or by the legal guardian, if appointed

Exclusion criteria

  • INR > 1.5
  • aPTT > 1.5
  • Platelet count < 75,000/mm³
  • Signs suggestive of infection at the puncture site
  • Absence of informed consent to the procedure
  • Documented or suspected allergy to local anesthetics

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Ospedale Edoardo Bassini — Cinisello Balsamo

Identifiers

NCT: NCT07284615 · 5967

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗