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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty (PENG-LFCN-EEG)

2 novembre 2026 aggiornato da: Kocaeli City Hospital

Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial

This prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip arthroplasty.

A total of 50 adult patients will be randomly allocated to two groups: combined PENG and LFCN blocks followed by general anaesthesia, or general anaesthesia alone. Anaesthetic depth will be monitored using the SedLine EEG monitoring system.

The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include remifentanil consumption, EEG-derived parameters including Patient State Index (PSI) and suppression ratio, haemodynamic variables, and recovery characteristics.

The study aims to determine whether combined regional blocks reduce anaesthetic requirements while maintaining adequate EEG-guided anaesthetic depth.

Panoramica dello studio

Descrizione dettagliata

Total hip arthroplasty is frequently associated with significant nociceptive stimulation during surgery. Regional anaesthesia techniques, including the pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, may reduce intraoperative nociceptive input and consequently decrease anaesthetic and opioid requirements.

This prospective, randomized controlled trial will include 50 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective total hip arthroplasty.

Patients will be randomly assigned in a 1:1 ratio to either an intervention group receiving combined ultrasound-guided PENG and LFCN blocks before general anaesthesia or a control group receiving general anaesthesia without preoperative regional blocks.

General anaesthesia will be administered using a standardized EEG-guided protocol. During induction, propofol will be titrated to achieve a target Patient State Index (PSI) of 25-50, as monitored by the SedLine system. Following tracheal intubation, anaesthesia will be maintained with sevoflurane, with continuous EEG monitoring to maintain the target PSI range.

The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include total remifentanil consumption, EEG-derived anaesthetic depth parameters, suppression ratio measurements, the occurrence and duration of burst suppression, intraoperative haemodynamic variables, and postoperative recovery characteristics.

By comparing anaesthetic consumption and EEG-derived parameters between the two groups, this study aims to evaluate the effects of combined PENG and LFCN blocks on intraoperative anaesthetic requirements and EEG-guided anaesthetic depth during total hip arthroplasty.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: AYSE SENCAN, M.D Anaesthesiology Specialist
  • Numero di telefono: +905078313235
  • Email: draysesencan@gmail.com

Luoghi di studio

    • Kocaeli
      • Köseköy, Kocaeli, Turchia (Türkiye), 41100
        • Kocaeli City Hospital
        • Contatto:
        • Contatto:
          • Ayse Zeynep Turan Civraz, Associated Professor
          • Numero di telefono: +905054695850
          • Email: ayse.zeynep@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective primary total hip arthroplasty
  • Undergoing general anaesthesia
  • Provision of written informed consent to participate in the study

Exclusion Criteria:

  • Known allergy to local anaesthetics
  • Contraindications to PENG or LFCN block
  • Infection at the planned block injection site
  • Coagulopathy or anticoagulant therapy considered unsuitable for regional anaesthesia
  • Chronic opioid use
  • Significant neurological disorders that may interfere with EEG assessment
  • Cognitive impairment preventing comprehension of the study protocol or provision of informed consent
  • Inability to perform SedLine monitoring
  • Inability to obtain written informed consent

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PENG + LFCN Block Group

Patients in this group will receive ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks before general anaesthesia. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50.

Ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks will be performed before induction of general anaesthesia. Both blocks will be administered as part of a combined regional anaesthesia technique to provide perioperative analgesia during total hip arthroplasty.

Comparatore attivo: No Intervention Group

Patients in this group will undergo general anaesthesia without preoperative peripheral nerve blocks. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50.

General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Remifentanil will be administered intraoperatively according to a standardized anaesthetic protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intraoperative Sevoflurane Consumption (ml/h)
Lasso di tempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

Intraoperative sevoflurane consumption will be recorded in millilitres (mL) using the anaesthesia workstation. Hourly sevoflurane consumption will be calculated by dividing the total consumption by the duration of sevoflurane administration in hours.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
Lasso di tempo: From initiation to discontinuation of remifentanil infusion during general anaesthesia.

Weight-adjusted hourly remifentanil consumption will be determined by dividing the total administered remifentanil dose (µg) by patient body weight (kg) and the duration of remifentanil infusion in hours.

From initiation to discontinuation of remifentanil infusion during general anaesthesia.
Mean Intraoperative Patient State Index (PSI)
Lasso di tempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The mean Patient State Index (PSI) during sevoflurane anaesthesia will be determined using continuous EEG monitoring data obtained from the SedLine system.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Mean Intraoperative Suppression Ratio (SR)
Lasso di tempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The mean suppression ratio (SR) will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia and expressed as a percentage (%).

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Percentage of Time With Suppression Ratio Above 5%
Lasso di tempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The percentage of time during which the suppression ratio (SR) exceeds 5% will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Time to Extubation (min)
Lasso di tempo: From discontinuation of sevoflurane administration until tracheal extubation.

Time to extubation will be defined as the interval between discontinuation of sevoflurane administration and removal of the endotracheal tube, expressed in minutes.

From discontinuation of sevoflurane administration until tracheal extubation.
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
Lasso di tempo: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Postoperative sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from -5 (unarousable) to +4 (combative), with 0 indicating an alert and calm state.

At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
Lasso di tempo: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Postoperative delirium-related symptoms will be assessed using the Nursing Delirium Screening Scale (NuDESC) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from 0 to 10, with higher scores indicating more pronounced delirium-related symptoms.

At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

23 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 ottobre 2026

Primo Inserito (Effettivo)

29 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • PENG-LFCN-THA-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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