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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Heathcare Hamilton
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
|
|
Placebo-vergelijker: Placebo femoral nerve block
Sterile normal saline solution
|
Nerve block in lingual crease using ultrasound guidance
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.
Tijdsspanne: Three months
|
Three months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of eligible patients consenting to participate.
Tijdsspanne: Three months
|
Three months
|
|
Number of patients participating that were randomized and received the study intervention.
Tijdsspanne: Three months
|
Three months
|
|
Completion of study data collection forms
Tijdsspanne: Three months
|
Three months
|
|
Incidence of respiratory depression and seizures in participating subjects
Tijdsspanne: Three months
|
Three months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Mauricio Forero, MD, St. Joseph's Healthcare Hamilton
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Postoperatieve complicaties
- Pathologische processen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Pijn, postoperatief
- Organische chemicaliën
- Koolwaterstoffen
- Koolwaterstoffen, cyclisch
- Koolwaterstoffen, aromatisch
- Anilides
- Amides
- Aniline -verbindingen
- Amines
- Catechols
- Fenolen
- Benzeenderivaten
- Alcohol
- Aminoalcoholen
- Ethanolamines
- Biogene monoamine
- Biogene amines
- Catecholamines
- Bupivacaïne
- Epinefrine
Andere studie-ID-nummers
- 12-3688
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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