- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01911949
USFIB at the Inguinal Ligament for Total Hip Arthroplasty
An Ultrasound Guided Fascia Iliaca Block Placed at the Level of the Inguinal Ligament for Analgesia After Hip Arthroplasty
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Ultrasound guided femoral blocks have been studied since the late 90's. A study published in 1997 by Marhofer et al. pointed that ultrasound guidance in a 3-in-1 block (femoral, obturator, lateral cutaneous nerves), improved the quality of the sensory block and reduced the onset time when compared with a nerve-stimulation technique in patients undergoing hip surgery after trauma.(13) In a meta-analysis comparing ultrasound guidance versus electrical nerve-stimulation for peripheral nerve blocks, the authors reported a decreased risk of block failure, shorter procedure time and faster onset time when ultrasound is used.(14)
A systematic review studying the outcomes after Total Hip Arthroplasty concluded that when compared with systemic analgesia the use of femoral nerve block was on unclear benefit.(15) Separate analysis of the two studies included showed that in the Biboulet study, ultrasound was not used to perform the blocks, and pain with activity was not evaluated in the first 24 hours after surgery, time in which the maximum benefit of blocks is observed.(16) In the second study by Singelyn et al. with continuous femoral nerve block, the authors found similar pain relief than with IV Patient Controlled Analgesia morphine with fewer side effects.(17)
While recent publications have demonstrated the analgesia effectiveness of femoral nerve block and fascia iliaca block for hip fractures,(18) there are not references in the literature analyzing the effectiveness of a single shot, ultrasound-guided, femoral nerve block in primary hip arthroplasty. This fact opens up the possibility to continue researching the analgesic effectiveness of this block in a population where the options for handling postoperative pain are limited widely for its side effects together with the use of anticoagulant and anti-thrombotic therapy.
This technique is considered a simple procedure, easy to teach and to learn. If our study shows improvement of the outcomes, it will feasible to incorporate this block as an alternative for pain management after primary hip arthroplasty.
Given the complexity of this proposed randomized-controlled trial, a pilot study was deemed necessary to find out the feasibility and safety of the intervention, rate of patient recruitment and needs for additional personnel.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Heathcare Hamilton
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients 18 years or older undergoing unilateral hip arthroplasty.
- Patient capable to complete informed consent.
Exclusion Criteria:
- Pediatric population.
- Inability to complete informed consent.
- Patient refusal.
- Contraindication for regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, local or systemic infection, local anesthesia allergy.
- Presence of neuromuscular deficit including diabetic peripheral neuropathy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Single shot femoral nerve block
Ultrasound guided Femoral Nerve Block-40ml of bupivacaine 0.5% with epinephrine
|
Nerve block in lingual crease using ultrasound guidance
Andre navne:
|
|
Placebo komparator: Placebo femoral nerve block
Sterile normal saline solution
|
Nerve block in lingual crease using ultrasound guidance
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.
Tidsramme: Three months
|
Three months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of eligible patients consenting to participate.
Tidsramme: Three months
|
Three months
|
|
Number of patients participating that were randomized and received the study intervention.
Tidsramme: Three months
|
Three months
|
|
Completion of study data collection forms
Tidsramme: Three months
|
Three months
|
|
Incidence of respiratory depression and seizures in participating subjects
Tidsramme: Three months
|
Three months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mauricio Forero, MD, St. Joseph's Healthcare Hamilton
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Smerter, postoperativ
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Adrenerge alfa-agonister
- Adrenerge agonister
- Bedøvelsesmidler, lokale
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-agonister
- Sympatomimetika
- Vasokonstriktormidler
- Mydriatics
- Bupivacain
- Adrenalin
Andre undersøgelses-id-numre
- 12-3688
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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