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Drei Varianten des PENG-Blocks mit und ohne perineurale Adjuvantien bei älteren Erwachsenen

5. November 2026 aktualisiert von: Poznan University of Medical Sciences

Vergleich von Standard-PENG-Block versus PENG mit perineuralem Dexamethason oder perineuralem Dexmedetomidin bei Patienten im Alter von 65 Jahren und älter, die sich einer Hüftoperation unterziehen: Eine randomisierte kontrollierte Studie

This study will compare three versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing hip surgery. The PENG block is a regional anesthesia technique used to reduce pain around the hip joint and may improve early recovery after surgery.

All patients in the study will receive the PENG block using 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:

Group 1: PENG block using ropivacaine only (no additional medications). Group 2: PENG block using ropivacaine with 4 mg of dexamethasone injected near the nerves.

Group 3: PENG block using ropivacaine with 25 micrograms of dexmedetomidine injected near the nerves.

Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of regional anesthesia. It is not known whether adding one of these medications provides longer-lasting or better pain relief compared to using ropivacaine alone.

The main purpose of this study is to determine whether the addition of dexamethasone or dexmedetomidine improves the effectiveness of the PENG block in relieving pain after hip surgery. The study will evaluate pain levels, opioid consumption, time to first rescue pain medication, need for additional analgesia, and recovery outcomes. Safety, side effects, and any block-related complications will also be monitored.

The investigators hypothesize that adding either perineural dexamethasone or dexmedetomidine will result in longer and more effective pain relief compared with the standard PENG block without an adjuvant.

This research may help identify the most effective form of the PENG block for older adults undergoing hip surgery and contribute to improved pain management, reduced opioid use, and better postoperative recovery.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Hip surgery in older adults is frequently associated with significant postoperative pain, delayed mobilization, and increased opioid requirements. Poor pain control in this population can lead to complications such as delirium, prolonged hospitalization, reduced physical function, and slower rehabilitation. Effective regional anesthesia may improve safety and recovery after hip surgery.

The Pericapsular Nerve Group (PENG) block is a relatively new regional anesthesia technique designed to target the sensory innervation of the hip joint while preserving motor function. This motor-sparing feature may allow earlier mobilization and reduce the negative effects of immobilization in older patients.

Ropivacaine is the standard local anesthetic commonly used in peripheral nerve blocks. Small doses of adjuvant medications such as dexamethasone or dexmedetomidine may prolong the duration of analgesia and improve the quality of pain control. However, it remains unclear whether the addition of these medications provides any clinically meaningful benefit when used with the PENG block in older adults. There is also limited evidence directly comparing different adjuvants to a standard PENG block without additional medication.

This randomized controlled trial will compare three variants of the PENG block in adults aged 65 years and older undergoing hip surgery. All participants will receive a PENG block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:

Standard PENG block with ropivacaine alone (no adjuvant). PENG block with 4 mg of perineural dexamethasone. PENG block with 25 micrograms of perineural dexmedetomidine. All patients will receive standard perioperative care and multimodal analgesia. The study will assess pain scores, time to first rescue analgesia, total opioid consumption, functional mobility, incidence of postoperative nausea and vomiting, block duration, motor function, and complications. Safety will also be monitored, including block-related and neurological adverse events.

The primary objective of this study is to determine whether perineural dexamethasone or dexmedetomidine improves postoperative analgesia compared with a standard PENG block without adjuvant. The investigators hypothesize that both adjuvants may prolong analgesia and reduce opioid requirements, but their effectiveness and safety profile may differ.

This study aims to provide evidence that can help guide anesthesiologists in selecting the optimal variant of the PENG block for older adults undergoing hip surgery, intending to improve postoperative pain control, support early rehabilitation, and reducing complications associated with opioid use and delayed mobilization.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

120

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Polen
      • Poznan, Polen, 62-701
        • Poznan University of Medical Sciences

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

65 Jahre bis 100 Jahre (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 65 years or older
  • Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
  • ASA physical status I-III
  • Planned use of a PENG block as part of perioperative analgesia
  • Ability to communicate pain intensity using the NRS scale
  • Written informed consent obtained from the patient or legal representative

Exclusion Criteria:

  • Refusal or inability to provide informed consent
  • Known allergy, intolerance, or contraindication to any of the study medications: ropivacaine, dexamethasone, dexmedetomidine
  • Pre-existing neurological deficit or neuropathy in the affected limb
  • Coagulopathy or laboratory abnormality that contraindicates regional anesthesia: INR >1.5, or platelet count <100,000/µL, or therapeutic anticoagulation that cannot be safely paused
  • Infection at or near the needle insertion site
  • Severe hepatic or renal impairment
  • Chronic opioid therapy (>30 days of daily opioids before surgery)
  • Cognitive impairment or delirium that prevents reliable pain assessment
  • BMI >40 kg/m² (due to potential technical difficulty and reduced accuracy of ultrasound guidance)
  • Previous regional block affecting the target area for the current surgery
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial within 30 days

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: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: PENG Block With Ropivacaine Only (Control)

Participants will receive a Pericapsular Nerve Group (PENG) block using 20 mL of 0.2% ropivacaine without any adjuvant administered perineurally or intravenously. All participants will receive standard perioperative care and multimodal analgesia. Ondansetron will be used as standard prophylaxis for postoperative nausea and vomiting.
Arzneimittel: Ropivacaine 0.2% Injectable Solution

20 mL of 0.2% ropivacaine administered perineurally as part of the PENG block. No perineural or intravenous adjuvant drugs will be used in this arm.
Aktiver Komparator: PENG Block With Perineural Dexamethasone

Participants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 4 mg of dexamethasone administered perineurally. No dexamethasone will be given intravenously. All participants will receive standard perioperative care and multimodal analgesia.
Arzneimittel: Dexamethasone 4mg

4 mg of dexamethasone administered perineurally together with 20 mL of 0.2% ropivacaine for the PENG block. No intravenous dexamethasone will be administered.
Aktiver Komparator: PENG Block With Perineural Dexmedetomidine

Participants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine administered perineurally. No dexamethasone will be given intravenously. All participants will receive standard perioperative care and multimodal analgesia.
Arzneimittel: Dexmedetomidine

25 micrograms of dexmedetomidine administered perineurally together with 20 mL of 0.2% ropivacaine for the PENG block. No intravenous dexamethasone will be administered.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to First Rescue Analgesia
Zeitfenster: Within 48 hours after surgery.

Time (in hours) from completion of the PENG block to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).
Within 48 hours after surgery.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Intensity at Rest (NRS 0-10)
Zeitfenster: 4 hours after surgery.

Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.
4 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Zeitfenster: 8 hours after surgery.

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.
8 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Zeitfenster: 12 hours after surgery.

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.
12 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Zeitfenster: 24 hours after surgery.

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.
24 hours after surgery.
Pain Intensity at Rest (NRS 0-10)
Zeitfenster: 48 hours after surgery.

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.
48 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Zeitfenster: 4 hours after surgery.

Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.
4 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Zeitfenster: 8 hours after surgery.

Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.
8 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Zeitfenster: 12 hours after surgery.

Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.
12 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Zeitfenster: 24 hours after surgery.

Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.
24 hours after surgery.
Pain Intensity During Movement (NRS 0-10)
Zeitfenster: 48 hours after surgery.

Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.
48 hours after surgery.
Total Opioid Consumption
Zeitfenster: 0-24 hours and 0-48 hours after surgery.

Cumulative dose of opioids converted to oral morphine milligram equivalents (MME).
0-24 hours and 0-48 hours after surgery.
Motor Function Preservation (Quadriceps Strength, MRC Scale)
Zeitfenster: 4 hours after surgery.

Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.
4 hours after surgery.
Motor Function Preservation (Quadriceps Strength, MRC Scale)
Zeitfenster: 8 hours after surgery.

Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.
8 hours after surgery.
Motor Function Preservation (Quadriceps Strength, MRC Scale)
Zeitfenster: 12 hours after surgery.

Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.
12 hours after surgery.
Motor Function Preservation (Quadriceps Strength, MRC Scale)
Zeitfenster: 24 hours after surgery.

Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.
24 hours after surgery.
Motor Function Preservation (Quadriceps Strength, MRC Scale)
Zeitfenster: 48 hours after surgery.

Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.
48 hours after surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Zeitfenster: 0-48 hours after surgery.

Presence of nausea or vomiting requiring antiemetic therapy. Proportion of patients with at least one episode will be recorded.
0-48 hours after surgery.
Hemodynamic Adverse Events
Zeitfenster: From block placement until 24 hours after surgery.

Incidence of hypotension (systolic BP <90 mmHg or >30% decrease from baseline) and bradycardia (HR <50/min) requiring treatment.
From block placement until 24 hours after surgery.
Block-Related Adverse Events, Including Neurological Complications
Zeitfenster: From block placement until 30 days after surgery.

Incidence of complications related to the PENG block or perineural adjuvants, including prolonged sensory or motor deficit, nerve injury (evaluated in outpatient clinic if required), hematoma, infection at the injection site, persistent weakness, or local anesthetic systemic toxicity.
From block placement until 30 days after surgery.

Mitarbeiter und Ermittler

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

Sponsor

Poznan University of Medical Sciences

Ermittler

  • Studienstuhl: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences

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 (Tatsächlich)

13. Februar 2026

Primärer Abschluss (Tatsächlich)

20. Mai 2026

Studienabschluss (Tatsächlich)

17. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

28. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Dezember 2025

Zuerst gepostet (Tatsächlich)

9. Januar 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 10/2025

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data (IPD) that support the results of this study will be made available to other researchers. Shared IPD will include demographic information, clinical outcomes, adverse events, and all primary and secondary outcome variables collected during the study. No information that could identify participants will be included.

IPD-Sharing-Zeitrahmen

IPD will be available beginning 12 months after publication of the primary results and will remain available for 5 years after publication.

IPD-Sharing-Zugriffskriterien

Data will be shared with qualified researchers for scientific purposes upon reasonable request. Requests will be evaluated by the study investigators. A data sharing agreement may be required.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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