Can the Femoral Nerve Block be Improved by Ultrasound Guidance?
11. juni 2008 opdateret af: NHS Greater Glasgow and Clyde
Can the Use of Ultrasound to Guide the Insertion of a Needle for an Anterior Psoas Compartment Nerve Block Increase Its Efficacy in Comparison to Traditional Techniques Utilising Loss of Resistance and Nerve Stimulation?
Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients.
This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint.
Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement.
The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded.
A standard anaesthetic and a hip replacement operation will then be performed.
Standard pain relief protocols will be used the operation and after the operation.
After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation.
The first day the patient is able to walk on their new hip replacement will also be recorded.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
269
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Lanarkshire
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Glasgow, Lanarkshire, Det Forenede Kongerige, G12 0YN
- Gartnavel General Hospital
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Glasgow, Lanarkshire, Det Forenede Kongerige, G4
- Glasgow Royal Infrimary
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Glasgow, Lanarkshire, Det Forenede Kongerige
- Golden Jubilee Hospital
-
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Renfrewshire
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Paisley, Renfrewshire, Det Forenede Kongerige, PA2
- Royal Alexandra Hospital
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-
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
35 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Elective primary total hip arthroplasty under general anaesthesia
- ASA<=4
- Able to give informed consent
- Able to cooperate with sensory and motor testing of lower limb function
Exclusion Criteria:
- Abnormal clotting screen (coagulopathy) or thrombocytopenia (<100,000)
- Acute mental test score of <=7 at any time pre or post operatively
- Allergy to local anaesthetic
- Signs, symptoms or laboratory evidence of local infection or systemic sepsis
- No pre-existing neurological deficit (sensory or motor) affecting lower limb
- Patients with lower limb amputations
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: loss of resistance
Anterior psoas compartment nerve block inserted using loss of resistance
|
Use of ultrasound to guide the insertion of anterior psoas compartment block
|
|
Aktiv komparator: nerve stimulator
Anterior psoas compartment nerve block inserted using nerve stimulator
|
Use of ultrasound to guide the insertion of anterior psoas compartment block
The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
|
|
Aktiv komparator: ultrasound
Anterior psoas compartment nerve block inserted using ultrasound
|
Use of ultrasound to guide the insertion of anterior psoas compartment block
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
percentage of patients with effective regional analgesia
Tidsramme: Induction of anaesthesia
|
Induction of anaesthesia
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
hospital mortality
Tidsramme: 1months after operation
|
1months after operation
|
|
sensory function in lateral cutaneous nerve
Tidsramme: 0mins, 10mins 20mins post insertion of local anaesthetic
|
0mins, 10mins 20mins post insertion of local anaesthetic
|
|
sensory function of femoral nerve
Tidsramme: 0mins, 10mins, 20mins after insertion of local anesthetic
|
0mins, 10mins, 20mins after insertion of local anesthetic
|
|
sensory function of obturator nerve
Tidsramme: 0mins, 10mins, 20mins after insertion of local anesthetic
|
0mins, 10mins, 20mins after insertion of local anesthetic
|
|
motor function of obturator nerve
Tidsramme: 0mins, 10mins and 20minutes after insrtion of local anesthetic
|
0mins, 10mins and 20minutes after insrtion of local anesthetic
|
|
motor function of femoral nerve
Tidsramme: 0mins,10mins and 20mins post insertion of local anesthetic
|
0mins,10mins and 20mins post insertion of local anesthetic
|
|
acute mental test scores
Tidsramme: 6hours and 24 hours post operatively
|
6hours and 24 hours post operatively
|
|
total morphine dose administered
Tidsramme: 6hours and 24 hours post operstively
|
6hours and 24 hours post operstively
|
|
day first mobilise post operatively
Tidsramme: post operatively 0-10 days
|
post operatively 0-10 days
|
|
patient satisfaction scores
Tidsramme: 6 hours and 24hours post operatively
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6 hours and 24hours post operatively
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Malcolm watson, MB ChB FRCA, NHS Greater Glasgow and Clyde
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
1. juli 2008
Primær færdiggørelse (Forventet)
1. juli 2010
Studieafslutning (Forventet)
1. august 2010
Datoer for studieregistrering
Først indsendt
9. juni 2008
Først indsendt, der opfyldte QC-kriterier
11. juni 2008
Først opslået (Skøn)
12. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. juni 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2008
Sidst verificeret
1. juni 2008
Mere information
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 .