Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

PENG+LFCN Block vs QIPB for Total Hip Arthroplasty

20. Juni 2026 aktualisiert von: Mustafa Kılın, Antalya City Hospital

Comparison Between Quadro-iliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve Block for Total Hip Arthroplasty: a Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve(LFCN) block in patients undergoing total hip arthroplasty. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, ıncidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block- related complications(hematoma,local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.

Studienübersicht

Detaillierte Beschreibung

Materials and Methods:

This prospective, randomized clinical trial will include patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective unilateral primary total hip arthroplasty unde spinal anesthesia. Before enrollment, all patients will be informed about the study protocol and written informed consent will be obtained. Patients will be instructed on the use of the Numeric Rating Scale (NRS) for postoperative pain assessment, where 0 represents no pain and 10 represents the worst pain imaginable.

Patients with contraindications to spinal anesthesia, allergy to local anesthetics, coagulopathy, infection at the injection site, chronic opioid use, pre-existing neurological deficits involving the lower extremities, cognitive impairment preventing reliable communication, revision or bilateral hip arthroplasty, and refusal to participate will be excluded from the study.

Patients will be randomly allocated to one of two study groups using a computer-generated randomization sequence (https://www.randomizer.org). Randomization will be performed by a team member not involved in patient management or outcome assessment. Allocation concealment will be achieved using sequentially numbered sealed opaque envelopes, which will be opened immediately before block performance.

Upon arrival in the operating room, standard monitoring including electrocardiography, non-invasive blood pressure measurement, and pulse oximetry will be applied. Following intravenous access and preloading according to institutional practice, spinal anesthesia will be performed at the L3-L4 or L4-L5 intervertebral space using a 25-gauge Quincke spinal needle under aseptic conditions. After confirmation of free cerebrospinal fluid flow, 12-15 mg of 0.5% hyperbaric bupivacaine will be administered intrathecally. Supplemental sedation with intravenous midazolam and/or propofol may be provided when required for patient comfort.

Following successful spinal anesthesia, patients will receive either ultrasound-guided quadro-iliac plane block (QIPB) or ultrasound-guided pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve block according to group allocation. All blocks will be performed by anesthesiologists experienced in regional anesthesia and familiar with both techniques.

All patients will receive the same multimodal postoperative analgesic regimen and standardized postoperative rehabilitation protocol. Postoperative pain scores at rest and during movement will be assessed using the NRS during the first 48 postoperative hours. Opioid consumption, incidence of quadriceps motor block, time to first ambulation, patient satisfaction, postoperative nausea and vomiting, falls, length of hospital stay, block performance time, and block-related complications will also be recorded.

Outcome assessments will be performed by investigators who are unaware of group allocation.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

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:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled for elective unilateral primary total hip arthroplasty
  • Surgery planned under spinal anesthesia
  • Ability to understand and use the Numeric Rating Scale
  • Written informed consent provided

Exclusion Criteria:

  • Refusal to participate
  • Revision total hip arthroplasty
  • Bilateral total hip arthroplasty
  • Contraindication to spinal anesthesia
  • Contraindication to peripheral nerve block
  • Known allergy to local anesthetics or study drugs
  • Coagulopathy or anticoagulant use incompatible with neuraxial/regional anesthesia
  • Infection at the block injection site
  • Pre-existing neurological deficit involving the operative lower extremity
  • Peripheral neuropathy
  • Chronic opioid use
  • Cognitive impairment or inability to communicate reliably
  • Severe hepatic or renal failure
  • Body mass index >35 kg/m²
  • Pregnancy

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: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: quadro-iliac plane block (QIPB)
Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after spinal anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.
Aktiver Komparator: pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve block
Participants in the PENG group will undergo an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia. A total of 20 mL of 0.25% bupivacaine will be administered.
Participants in the LFCN group will undergo an ultrasound-guided lateral femoral cutaneous nerve block after spinal anesthesia. A total of 10 mL of 0.25% bupivacaine will be administered.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative pain scores
Zeitfenster: Postoperative 6, 24, 36, and 48 hours
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores at rest will be recorded in the post-anesthesia care unit and at postoperative 6, 24, 36, and 48 hours. Pain scores during movement will be assessed during passive flexion of the operated hip at postoperative 6, 24, 36, and 48 hours.
Postoperative 6, 24, 36, and 48 hours

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative opioid consumption
Zeitfenster: Postoperative 24 and 48 hours
Total postoperative opioid consumption will be recorded and cumulative opioid consumption will be calculated at postoperative 24 and 48 hours.
Postoperative 24 and 48 hours
Incidence of quadriceps motor block
Zeitfenster: Postoperative 3, 6, and 24 hours

Quadriceps motor block will be assessed using knee extension testing and graded as:

0 = normal strength

  1. = paresis
  2. = paralysis. Motor block incidence will be defined as the presence of paresis or paralysis.
Postoperative 3, 6, and 24 hours
Patient satisfaction
Zeitfenster: Postoperative 48 hours
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
Postoperative 48 hours
Postoperative nausea and vomiting (PONV)
Zeitfenster: Postoperative 48 hours
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Postoperative 48 hours
Falls
Zeitfenster: Through postoperative day 2
Incidence of falls during the first 48 postoperative hours.
Through postoperative day 2
Length of hospital stay
Zeitfenster: Through hospital discharge, up to 30 days
Number of days from surgery to hospital discharge.
Through hospital discharge, up to 30 days
Time to first ambulation
Zeitfenster: Postoperative day 1
Time from the end of surgery to the first successful ambulation.
Postoperative day 1
Block performance time
Zeitfenster: Periprocedural
Time from ultrasound probe placement to completion of local anesthetic injection.
Periprocedural
Block-related complications
Zeitfenster: Through hospital discharge, up to 30 days
Hematoma Vascular puncture Local anesthetic systemic toxicity (LAST) Infection at the injection site
Through hospital discharge, up to 30 days

Mitarbeiter und Ermittler

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

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)

15. November 2026

Primärer Abschluss (Geschätzt)

15. August 2027

Studienabschluss (Geschätzt)

15. September 2027

Studienanmeldedaten

Zuerst eingereicht

13. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juni 2026

Zuerst gepostet (Tatsächlich)

25. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

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 .

Klinische Studien zur Schmerztherapie

Klinische Studien zur Quadro iliac Plane Block(QİPB)

3
Abonnieren