Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Comparison of Meta-PENG and Suprainguinal Fascia Iliaca Plane Block in Hip Fractures (META-SIFI)

Comparison of the Effects of Ultrasound-Guided Meta-PENG Block and Suprainguinal Fascia Iliaca Plane Block in Patients Undergoing Hip Fracture Surgery Under Spinal Anesthesia

This prospective observational single-center study will compare the effects of ultrasound-guided meta-PENG block and suprainguinal fascia iliaca plane block in patients undergoing hip fracture surgery under spinal anesthesia.

Hip fracture surgery can cause significant pain before, during, and after the operation. Regional anesthesia techniques may help reduce pain, improve positioning for spinal anesthesia, decrease the need for additional analgesics, and support earlier mobilization.

Patients included in the study will be adults scheduled for hip fracture surgery under spinal anesthesia. According to routine clinical practice and the anesthesiologist's decision, patients will receive either ultrasound-guided meta-PENG block or ultrasound-guided suprainguinal fascia iliaca plane block. The study will not assign patients to a treatment group by randomization.

The main outcome will be pain during positioning for spinal anesthesia, measured using the Numeric Rating Scale. Additional outcomes will include postoperative pain at rest and during activity, additional analgesic consumption, patient satisfaction, mobilization time, and length of hospital stay.

Studieoversigt

Detaljeret beskrivelse

Hip fractures are common, especially in older adults, and are associated with significant perioperative pain, delayed mobilization, increased analgesic requirements, and prolonged hospitalization. Effective perioperative pain control is important in this patient population because inadequate analgesia may impair positioning for spinal anesthesia, increase postoperative discomfort, and delay recovery.

Regional anesthesia techniques are frequently used as part of multimodal analgesia in patients undergoing hip fracture surgery. The suprainguinal fascia iliaca plane block is a regional block technique that may provide analgesia by affecting nerves related to the lumbar plexus, including the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. The pericapsular nerve group block and modified techniques, including meta-PENG block, aim to provide analgesia by targeting articular branches involved in hip joint innervation.

This study is designed as a prospective observational single-center study. Adult patients with ASA physical status I-III who are scheduled to undergo hip fracture surgery under spinal anesthesia will be evaluated for eligibility. Patients who provide written informed consent, or whose legal representative provides consent when applicable, will be included.

The regional block technique will be determined according to routine clinical practice and the responsible anesthesiologist's preference. Patients will not be randomized by the study protocol. Patients will be observed in two groups: those receiving ultrasound-guided meta-PENG block and those receiving ultrasound-guided suprainguinal fascia iliaca plane block.

The primary outcome of the study is pain during positioning for spinal anesthesia. Pain will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Secondary outcomes will include postoperative Numeric Rating Scale scores at rest and during activity, including back raising and hip flexion; additional analgesic consumption; patient satisfaction assessed using the OR-15 questionnaire; time to mobilization; and length of hospital stay.

Intraoperative data, spinal anesthesia medication dose, regional block and anesthesia methods, postoperative pain scores, additional analgesic requirements, mobilization time, patient satisfaction, and hospitalization duration will be recorded from the hospital information system and anesthesia records.

The study will be conducted at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital. The study has been reviewed and approved by the institutional scientific research ethics committee.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Şule Altuncu, MD
  • Telefonnummer: +90 539 910 1999

Studiesteder

    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34000
        • Rekruttering
        • Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients scheduled to undergo hip fracture surgery under spinal anesthesia at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital will be included. Eligible patients will be ASA physical status I-III and will receive either ultrasound-guided meta-PENG block or ultrasound-guided suprainguinal fascia iliaca plane block as part of routine perioperative analgesia management.

Beskrivelse

Inclusion Criteria:

  • Age greater than 18 years
  • ASA physical status I-III
  • Scheduled to undergo hip fracture surgery under spinal anesthesia
  • Written informed consent obtained from the patient or the patient's legal representative

Exclusion Criteria:

  • Refusal to participate in the study
  • ASA physical status IV-V
  • Presence of central or autonomic nervous system disease
  • Known allergy to the drugs used in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Meta-PENG Block Group
Patients undergoing hip fracture surgery under spinal anesthesia who receive ultrasound-guided meta-PENG block as part of routine perioperative analgesia management.
Ultrasound-guided meta-PENG block performed as part of routine perioperative regional analgesia management in patients undergoing hip fracture surgery under spinal anesthesia.
Suprainguinal Fascia Iliaca Plane Block Group
Patients undergoing hip fracture surgery under spinal anesthesia who receive ultrasound-guided suprainguinal fascia iliaca plane block as part of routine perioperative analgesia management.
Ultrasound-guided suprainguinal fascia iliaca plane block performed as part of routine perioperative regional analgesia management in patients undergoing hip fracture surgery under spinal anesthesia.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain During Positioning for Spinal Anesthesia
Tidsramme: During the positioning for spinal anesthesia, immediately before spinal needle insertion(Periprocedural)
Pain intensity during positioning for spinal anesthesia will be assessed using the Numeric Rating Scale. The Numeric Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
During the positioning for spinal anesthesia, immediately before spinal needle insertion(Periprocedural)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Sule Altuncu, MD, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

23. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the study includes patient clinical data and no data sharing plan was specified in the approved study protocol.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Ultrasound-Guided Meta-PENG Block

Abonner