- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8N 4A6
- St. Joseph's Heathcare Hamilton
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Placebo-jämförare: Placebo femoral nerve block
Sterile normal saline solution
|
Nerve block in lingual crease using ultrasound guidance
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.
Tidsram: Three months
|
Three months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of eligible patients consenting to participate.
Tidsram: Three months
|
Three months
|
|
Number of patients participating that were randomized and received the study intervention.
Tidsram: Three months
|
Three months
|
|
Completion of study data collection forms
Tidsram: Three months
|
Three months
|
|
Incidence of respiratory depression and seizures in participating subjects
Tidsram: Three months
|
Three months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mauricio Forero, MD, St. Joseph's Healthcare Hamilton
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Postoperativa komplikationer
- Patologiska processer
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Smärta, postoperativt
- Organiska kemikalier
- Kolväten
- Kolväten, cykliska
- Kolväten, aromatisk
- Anilider
- Amider
- Anilinföreningar
- Aminer
- Katekoler
- Fenoler
- Bensiverivat
- Alkohol
- Aminohalkalkol
- Etanolaminer
- Biogena monoaminer
- Biogena aminer
- Katekolaminer
- Bupivakain
- Adrenalin
Andra studie-ID-nummer
- 12-3688
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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