- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Sule Altuncu, MD
- Telefonní číslo: +90 216 606 33 00
- E-mail: sule.621@hotmail.com
Studijní záloha kontaktů
- Jméno: Şule Altuncu, MD
- Telefonní číslo: +90 539 910 1999
Studijní místa
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye), 34000
- Nábor
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
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Kontakt:
- Sule Altuncu, MD
- Telefonní číslo: +90 216 606 33 00
- E-mail: sule.621@hotmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain During Positioning for Spinal Anesthesia
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Sule Altuncu, MD, Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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