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Pericapsular Nerve Group Block Versus Femoral Nerve Block Study

16 luglio 2026 aggiornato da: Taksim Egitim ve Arastirma Hastanesi

Comparison of Preoperative Pericapsular Nerve Group (PENG) Block Versus Femoral Nerve Block for Optimizing Spinal Anaesthesia in Proximal Femur Fracture Surgery: A Prospective Randomized Controlled Trial

Hip fractures are common in older adults and are often associated with severe pain, making it difficult for patients to sit for spinal anesthesia before surgery. Peripheral nerve blocks may improve pain control and facilitate patient positioning, but it remains uncertain whether the Pericapsular Nerve Group (PENG) block provides advantages over the traditional femoral nerve block during the spinal anesthesia procedure.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Hip fractures are among the most common injuries in older adults and are associated with substantial morbidity, mortality, and healthcare utilization. Spinal anesthesia is frequently used for surgical repair of proximal femur fractures because of its favorable safety profile in elderly patients. However, severe pain caused by the fracture often makes positioning for spinal anesthesia difficult, resulting in patient discomfort, prolonged procedure time, multiple needle insertion attempts, and increased procedural complexity.

Peripheral nerve blocks are increasingly used before spinal anesthesia to improve analgesia and facilitate patient positioning. The femoral nerve block (FNB) has long been established as an effective regional anesthesia technique for patients with hip fractures. More recently, the ultrasound-guided Pericapsular Nerve Group (PENG) block has been introduced as a motor-sparing technique targeting the articular branches of the femoral, obturator, and accessory obturator nerves that innervate the anterior hip capsule. Previous studies have demonstrated that the PENG block provides effective analgesia during positioning for spinal anesthesia and may offer superior pain relief compared with conventional techniques. However, evidence comparing the effects of PENG block and femoral nerve block on the technical performance of spinal anesthesia and perioperative hemodynamic stability remains limited.

This prospective, randomized controlled trial is designed to compare ultrasound-guided PENG block with ultrasound-guided femoral nerve block in patients undergoing surgery for proximal femur fracture under spinal anesthesia. The study will evaluate whether PENG block improves procedural conditions for spinal anesthesia compared with femoral nerve block while also assessing perioperative analgesia and hemodynamic responses.

The study hypothesis is that preoperative PENG block will provide better procedural conditions for spinal anesthesia than femoral nerve block by improving patient positioning, reducing pain during positioning, facilitating spinal needle placement, decreasing the need for supplemental analgesic or sedative medication, and contributing to greater perioperative hemodynamic stability.

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

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

Luoghi di studio

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Adults aged 50 years or older.
  • Diagnosis of proximal femoral fracture.
  • Scheduled to undergo surgical repair under spinal anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Refusal to participate or inability to provide informed consent.
  • Coagulopathy or contraindication to spinal anesthesia or peripheral nerve block.
  • Local infection at the planned injection site.
  • Known allergy or hypersensitivity to local anesthetics.
  • Pre-existing neurological disease affecting lower extremity function or sensory assessment.
  • Cognitive impairment preventing reliable study participation or outcome assessment.
  • Previous lumbar spine surgery.
  • Polytrauma.
  • Body mass index (BMI) <18 kg/m² or >40 kg/m².
  • Current anticoagulant therapy that precludes neuraxial anesthesia or peripheral nerve block according to institutional practice.

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: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: PENG Block
Participants will receive a preoperative ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery. Spinal anesthesia will subsequently be performed according to the standardized study protocol.
Procedura: Ultrasound-Guided Pericapsular Nerve Group (PENG) Block
Ultrasound-guided PENG block performed before spinal anesthesia using 20 mL of 0.25% bupivacaine to provide analgesia for patients undergoing surgery for proximal femur fracture.
Procedura: Spinal Anesthesia (bupivacaine)
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
Comparatore attivo: Femoral Nerve Block
Participants will receive a preoperative ultrasound-guided femoral nerve block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery. Spinal anesthesia will subsequently be performed according to the standardized study protocol.
Procedura: Spinal Anesthesia (bupivacaine)
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
Procedura: Ultrasound-Guided Femoral Nerve Block
Ultrasound-guided femoral nerve block performed before spinal anesthesia using 20 mL of 0.25% bupivacaine to provide analgesia for patients undergoing surgery for proximal femur fracture.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Spinal Anesthesia Convenience Score (SACS)
Lasso di tempo: During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)
Spinal anesthesia convenience will be assessed using the Spinal Anesthesia Convenience Score (SACS), a composite clinical score evaluating the ease of spinal anesthesia based on anatomical landmark palpation, patient cooperation, sitting position quality, pain during passive hip flexion, and pain while maintaining the sitting position. Total scores range from 0 to 11, with higher scores indicating easier spinal anesthesia conditions.
During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
First-Attempt Success of Spinal Anesthesia
Lasso di tempo: During the spinal anesthesia procedure.
The proportion of participants in whom successful intrathecal access is achieved on the first needle insertion attempt.
During the spinal anesthesia procedure.
Number of Spinal Needle Insertion Attempts
Lasso di tempo: During the spinal anesthesia procedure.
The total number of spinal needle insertion attempts required to achieve successful spinal anesthesia.
During the spinal anesthesia procedure.
Duration of Spinal Anesthesia Procedure
Lasso di tempo: During the spinal anesthesia procedure.
Time from the beginning of patient positioning until completion of spinal anesthesia and return to the supine position, measured in minutes.
During the spinal anesthesia procedure.
Anxiety Score
Lasso di tempo: Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).
Patient anxiety will be assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no anxiety) to 10 (maximum anxiety). Lower scores indicate less anxiety.
Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).
Patient Satisfaction
Lasso di tempo: Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])
Patient satisfaction with the anesthesia process will be assessed using a Numeric Rating Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied). Higher scores indicate greater satisfaction.
Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])
Anesthesiologist Satisfaction
Lasso di tempo: Immediately after completion of spinal anesthesia.
The anesthesiologist's satisfaction with procedural conditions will be assessed using a Numeric Rating Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied). Higher scores indicate greater satisfaction.
Immediately after completion of spinal anesthesia.
Perioperative Hemodynamic Parameters
Lasso di tempo: Before peripheral nerve block; 1, 5, 10, 15, and 30 minutes after block placement; and 1, 5, 10, 15, and 30 minutes after spinal anesthesia.
Mean arterial blood pressure will be recorded throughout the perioperative period.
Before peripheral nerve block; 1, 5, 10, 15, and 30 minutes after block placement; and 1, 5, 10, 15, and 30 minutes after spinal anesthesia.
Incidence of Hypotension
Lasso di tempo: From spinal anesthesia until 30 minutes after surgery completed.
Hypotension is defined as a mean arterial pressure below 65 mmHg. The proportion of participants experiencing hypotension will be recorded.
From spinal anesthesia until 30 minutes after surgery completed.
Vasopressor Requirement
Lasso di tempo: From spinal anesthesia until 30 minutes after surgery completed.
Total intravenous ephedrine dose administered for the treatment of hypotension, measured in milligrams.
From spinal anesthesia until 30 minutes after surgery completed.
Additional Analgesic Medication Requirement
Lasso di tempo: During the spinal anesthesia procedure.
Total doses of intravenous fentanyl (micrograms) administered during positioning for spinal anesthesia.
During the spinal anesthesia procedure.
Additional Sedative Medication Requirement
Lasso di tempo: During the spinal anesthesia procedure.
Total doses of intravenous midazolam (milligrams) administered during positioning for spinal anesthesia.
During the spinal anesthesia procedure.

Collaboratori e investigatori

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

Sponsor

Taksim Egitim ve Arastirma Hastanesi

Investigatori

  • Investigatore principale: Celal Kaya, Taksim Training and Research Hospital

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.

Pubblicazioni generali

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)

20 luglio 2026

Completamento primario (Stimato)

10 dicembre 2026

Completamento dello studio (Stimato)

20 dicembre 2026

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2026

Primo Inserito (Effettivo)

21 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E-48670771-514.99-317908988

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Descrizione del piano IPD

There is no current plan to share individual participant data (IPD). Future data sharing may be considered upon reasonable request and subject to approval by the sponsor, institutional policies, and applicable ethical and legal requirements.

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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