- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07687290
Comparative Study Between Pericapsular Nerve Group Block (PENG) And Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block for Positioning Analgesia Prior to Spinal Anesthesia in Hip Fracture Patients
8. juli 2026 opdateret af: Maha Salah, Ain Shams University
To evaluate and compare the effectiveness of the Pericapsular Nerve Group (PENG) block alone versus the PENG block combined with the Lateral Femoral Cutaneous Nerve (LFCN) block in providing adequate analgesia for patient positioning during spinal anesthesia in individuals undergoing surgery for hip fracture.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hip fractures are common among adult patients and often necessitate urgent surgical intervention.
Positioning these patients for spinal anesthesia in sitting position is often difficult due to intense pain from the fracture.
PENG block is a novel regional technique that targets the articular branches of the femoral nerve, obturator nerve, and accessory obturator nerve, providing excellent anterior hip analgesia sparing the motor function.
It is performed under ultrasound guidance and has shown promising results in perioperative pain management.
By combining LFCN block with the PENG block, more complete sensory blockade may be achieved.
The effectiveness of this combination has not yet been adequately studied, particularly regarding positioning for spinal anesthesia.
Therefore, this trial aims to compare the analgesic efficacy of PENG block alone versus PENG +LFCN block in this specific context.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Maha Salah, lecturer
- Telefonnummer: +201007269331
- E-mail: mahata5deer@gmail.com
Studiesteder
-
-
-
Cairo, Egypten
- Rekruttering
- Ain Shams University
-
Kontakt:
- Maha Salah, lecturer
- Telefonnummer: +201007269331
- E-mail: mahata5deer@gmail.com
-
-
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:
- Age 18-70 years.
- ASA I-II.
- Confirmed primary unilateral hip fracture.
- Scheduled for surgery under spinal anesthesia.
- Patients able to provide informed consent.
Exclusion Criteria:
- Allergy to local anesthetics.
- Coagulopathy or on anticoagulant therapy.
- Infection at injection site.
- Pre-existing neurological deficits in the lower limbs.
- Multiple trauma or polytrauma (If other injuries might interfere with positioning or pain scoring).
- Previous surgery on the ipsilateral hip affecting anatomy or nerve distribution.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group B (PENG block and LCFN block)
in addition to PENG block ( as described before), LFCN block is performed by using a linear array ultrasound probe a cross-sectional view of the LFCN was obtained by identifying the anterior superior iliac spine, then the probe is moved in a medial and caudal direction until the nerve was encountered.
The needle was advanced to the LFCN under ultrasound guidance via a lateral to medial approach.
Injection of 8ml of 0.25% of Bupivacaine (4 ml of Bupivacaine 0.5% is added to 4 ml of Lidocaine 2%)
|
Perikapsular nervegruppeblok
0.25% of Bupivacaine (Bupivacaine 0.5% is added to Lidocaine 2% in the same volume)
local infilteration at the insertion site
Lateral Femoral Cutaneous Nerve block
|
|
Aktiv komparator: group A (PENG BLOCK)
The patient is positioned supine and hip extended.
3 mL of 2% lidocaine is injected at the insertion site using a hyperechoic needle guided by ultrasound using a low-frequency probe.
At the anterior superior iliac spine level, the probe is placed parallel to the inguinal fold, and scanning is performed with a gradual movement of the probe head.
When the lower anterior inferior iliac spine is observed, the probe is rotated slightly median until a continuous hyperechoic shadow of the upper pubic ramus is visible.
This maneuver help to identify the psoas muscle with a prominent tendon above the pubic ramus.
The target is located in the plane between these 2 structures.
The pubic ramus should be aligned in the center of the image to target the pubic ramus just inside the anterior inferior iliac spine.
A 100-mm nerve block needle can be introduced, and 20 ml of 0.25% of Bupivacaine (10 ml of Bupivacaine 0.5% is added to 10ml of Lidocaine 2%) is administered
|
Perikapsular nervegruppeblok
0.25% of Bupivacaine (Bupivacaine 0.5% is added to Lidocaine 2% in the same volume)
local infilteration at the insertion site
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To compare the time taken to achieve optimal positioning for spinal anesthesia in both groups
Tidsramme: from initiation of patient positioning until optimal positioning is achieved during the spinal anesthesia procedure
|
time taken in seconds for positioning for spinal anesthesia 15 minutes post- block
|
from initiation of patient positioning until optimal positioning is achieved during the spinal anesthesia procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess Numerical Rating Pain Score in both groups at 0,5,10 and 15 minutes post block
Tidsramme: at baseline (0 minutes) and at 5,10 and 15 minutes after completion of the block
|
It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10 (0 = No pain 10 = Worst pain imaginable).
|
at baseline (0 minutes) and at 5,10 and 15 minutes after completion of the block
|
|
To assess patient satisfaction and comfort during positioning using Likert scale
Tidsramme: during patient positioning 15 minutes after completion of the block
|
5-Point scale (1=strongly disagree and 5=strongly agree).
The participants measure it 15 minutes post- block during positioning for spinal anesthesia
|
during patient positioning 15 minutes after completion of the block
|
|
To monitor mean arterial blood pressure
Tidsramme: at baseline (0 minutes) and at 5,10 and 15 minutes after completion of the block
|
Comparing mean arterial blood pressure between the 2 groups by millimeter of mercury (mmhg) at 0,5,10 and 15 minutes post-block.
|
at baseline (0 minutes) and at 5,10 and 15 minutes after completion of the block
|
|
To monitor heart rate
Tidsramme: At baseline (0 minutes) and at 5,10 and 15 minutes after completion of the block
|
Comparing the heart rate ( by beats per minute) in the 2 groups at 0,5,10 and 15 minutes post-block.
|
At baseline (0 minutes) and at 5,10 and 15 minutes after completion of the block
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
18. juni 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
18. juni 2026
Først indsendt, der opfyldte QC-kriterier
4. juli 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FMASU MS 25 / 2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .