- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07716358
Comparison Of Preoperative Ultrasound Guided Fascia Iliaca Block Versus Femoral Nerve Block for Proximal Femur Fractures Before Positioning for Spinal Anaesthesia
16. juli 2026 opdateret af: Dr Rafia Kousar, Sahara Medical College Narowal Pakistan
Proximal femur fractures are among the most painful orthopedic injuries Adequate analgesia is essential to facilitate positioning for spinal anesthesia, reduce opioid requirements, and minimize related complications.
The aim of study to compare the analgesic efficacy of preoperative ultrasound-guided Fascia Iliac Block Versus and Femoral Nerve Block in patients with proximal femur fractures prior to positioning for spinal anesthesia.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Punjab Province
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Chak Ninety-five North Branch, Punjab Province, Pakistan, 51600
- Sughra Shafi Medical Complex
-
-
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
Beskrivelse
Inclusion Criteria:
- ASA I&II status patients coming for proximal femur fracture surgery
Exclusion Criteria:
- Patients with history of neurological disease (Alzheimer, dementia),
- Patients with known contraindication to regional anaesthesia (e.g., signs of infection at site of block, coagulation abnormality i.e. INR >1.55, platelet count <80,000)
- Patients with ASA III and IV status and patients with Known allergy to the study drug were excluded from study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group A Participants who received Ultrasound Guided Femoral Nerve Block
Participants in group-A were 42 which were assigned randomly and Femoral Nerve Block was done before spinal anaesthesia.
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FNB was carried out as follows: the linear probe was kept in a "in line plane" approach to identify the femoral artery under ultrasound guidance.
The triangular, hyperechoic femoral nerve was identified as being situated lateral to the femoral artery.
The femoral artery was positioned next to an insulated 22 G needle.
Once the needle tip was located and a negative blood aspiration was obtained, a little amount of local anesthetic (injection bupivacaine 0.25%) was administered.
The remaining drug volume was injected based on weight (0.5 ml/kg) once the local anesthetic distribution was observed
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Aktiv komparator: Group B Participants who received Ultrasound Guided Fascia Iliaca Block
Participants in group- B were 42 which were assigned randomly and Fascia Iliaca Block was done before spinal anaesthesia.
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The FICB was administered as described.
We found the psoas muscle lateral to the femoral nerve.
The iliacus fascia, which extends deep into the fascia Lata, covers it.
Consequently, a double pop was felt after inserting the needle until it was between the psoas muscle and the fascia iliaca.
As with the previously described method, 1 mL of the local aesthetic solution was injected, and following a negative blood aspiration, the medication disseminated beneath the fascia iliaca.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Control
Tidsramme: 05 minutes
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In patients with proximal femur fractures pain assessment was done baseline before blocks and at five minutes after blocks administration.
Pain control assessment was done based on Visual Analogue Scale from 0-10.
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05 minutes
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
1. januar 2026
Primær færdiggørelse (Faktiske)
30. juni 2026
Studieafslutning (Faktiske)
30. juni 2026
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
16. juli 2026
Først opslået (Faktiske)
21. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12 (Israel lung Association)
Plan for individuelle deltagerdata (IPD)
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