- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07612761
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Sule Altuncu, MD
- Numero di telefono: +90 216 606 33 00
- Email: sule.621@hotmail.com
Backup dei contatti dello studio
- Nome: Şule Altuncu, MD
- Numero di telefono: +90 539 910 1999
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye), 34000
- Reclutamento
- Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
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Contatto:
- Sule Altuncu, MD
- Numero di telefono: +90 216 606 33 00
- Email: sule.621@hotmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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.
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Ultrasound-guided meta-PENG block performed as part of routine perioperative regional analgesia management in patients undergoing hip fracture surgery under spinal anesthesia.
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain During Positioning for Spinal Anesthesia
Lasso di tempo: During the positioning for spinal anesthesia, immediately before spinal needle insertion(Periprocedural)
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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.
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During the positioning for spinal anesthesia, immediately before spinal needle insertion(Periprocedural)
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Sule Altuncu, MD, Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Pai P, Amor D, Lai YH, Echevarria GC. Use and Clinical Relevancy of Pericapsular Nerve Block (PENG) in Total Hip Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2024 May 1;40(5):320-332. doi: 10.1097/AJP.0000000000001196.
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-273
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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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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Prove cliniche su Ultrasound-Guided Meta-PENG Block
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Aga Khan UniversityNon ancora reclutamento
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Cairo UniversityNon ancora reclutamentoAnestesia per la chirurgia dell'anca
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Ankara City Hospital BilkentReclutamentoOsteoartrosi (OA) dell'ancaTurchia (Türkiye)
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China-Japan Friendship HospitalNon ancora reclutamento
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Adiyaman University Research HospitalNon ancora reclutamentoFrattura dell'anca | Blocco del gruppo nervoso pericapsulare (blocco PENG) | Blocco soprainguinale di Fasya Iliaca
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Ankara City Hospital BilkentCompletatoRisposta infiammatoria | Fratture dell'anca | AnestesiaTurchia (Türkiye)
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Kirsehir Ahi Evran UniversitesiNon ancora reclutamentoBlocco PENG con o senza blocco PPD per l'analgesia postoperatoria dopo artroprotesi totale dell'ancaDolore postoperatorio | Protesi totale dell'anca (THA)
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University of LiegeCentre Hospitalier Universitaire de LiegeReclutamentoGestione del dolore postoperatorio | Blocco PENG | Blocchi nervosi periferici | Protesi totale dell'anca (THA) | Blocco nervoso iliopsoasBelgio
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Nanjing First Hospital, Nanjing Medical UniversityAttivo, non reclutante
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Campus Bio-Medico UniversityNon ancora reclutamentoProtesi totale dell'anca (THA) | Gestione del dolore postoperatorio dopo l'artroplastica totale dell'ancaItalia