Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
23. september 2010 oppdatert av: University of California, San Diego
The purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.
Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.
Studietype
Intervensjonell
Registrering (Forventet)
50
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Diego, California, Forente stater, 92103
- UCSD Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- primary, unilateral hip arthroplasty or hip resurfacing
- age greater than or equal to 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion
Exclusion Criteria:
- morbid obesity (BMI greater than 40)
- chronic, high-dose opioid use
- history of opioid abuse
- pregnancy
- incarceration
- amu meirp-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
- inability to communicate with hospital staff
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 1. Femoral Nerve Block
Patients will be randomized with a computer program to receive a femoral catheter.
The catheter will be placed using standard technique.
The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
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Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block.
Patients randomized to femoral nerve block will receive this block prior to surgery.
Patients randomized to psoas compartment nerve block will receive this block prior to surgery.
Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
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Aktiv komparator: 2. Psoas Compartment Catheter
Patients will be randomized with a computer program to receive a psoas compartment catheter.
The catheter will be placed using standard technique.
The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
|
Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block.
Patients randomized to femoral nerve block will receive this block prior to surgery.
Patients randomized to psoas compartment nerve block will receive this block prior to surgery.
Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system.
Tidsramme: 24 hours beginning 7:30am day following surgery
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24 hours beginning 7:30am day following surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Analgesic used, as reported by nursing staff in the UCSD computer system.
Tidsramme: 3 days following surgery
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3 days following surgery
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Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.
Tidsramme: 3 days following surgery
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3 days following surgery
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Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system.
Tidsramme: 3 days following surgery
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3 days following surgery
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Infusion duration of pain pump, measured on the pump itself in hours and minutes.
Tidsramme: 3 days following surgery
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3 days following surgery
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Duration of hospital stay, in hours, as reported in the UCSD computer system.
Tidsramme: 3 days following surgery
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3 days following surgery
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Surgical/anesthetic adverse events as reported by hospital staff
Tidsramme: day of surgery and 3 days following
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day of surgery and 3 days following
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Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery.
Tidsramme: 1 week following surgery
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1 week following surgery
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2009
Primær fullføring (Faktiske)
1. august 2010
Studiet fullført (Faktiske)
1. august 2010
Datoer for studieregistrering
Først innsendt
27. august 2009
Først innsendt som oppfylte QC-kriteriene
27. august 2009
Først lagt ut (Anslag)
28. august 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. september 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. september 2010
Sist bekreftet
1. september 2010
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Femoral vs. Psoas PNB Cath Hip
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