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Pericapsular Nerve Group Block Versus Femoral Nerve Block Study

16. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

110

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verfahren: 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.
Verfahren: Spinal Anesthesia (bupivacaine)
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
Aktiver Komparator: 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.
Verfahren: Spinal Anesthesia (bupivacaine)
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Spinal Anesthesia Convenience Score (SACS)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
First-Attempt Success of Spinal Anesthesia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During the spinal anesthesia procedure.
Total doses of intravenous midazolam (milligrams) administered during positioning for spinal anesthesia.
During the spinal anesthesia procedure.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Taksim Egitim ve Arastirma Hastanesi

Ermittler

  • Hauptermittler: Celal Kaya, Taksim Training and Research Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Juli 2026

Primärer Abschluss (Geschätzt)

10. Dezember 2026

Studienabschluss (Geschätzt)

20. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2026

Zuerst gepostet (Tatsächlich)

21. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E-48670771-514.99-317908988

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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