Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
23 september 2010 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
50
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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San Diego, California, Förenta staterna, 92103
- UCSD Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: 24 hours beginning 7:30am day following surgery
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24 hours beginning 7:30am day following surgery
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Analgesic used, as reported by nursing staff in the UCSD computer system.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 1 week following surgery
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1 week following surgery
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Samarbetspartners och utredare
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Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2009
Primärt slutförande (Faktisk)
1 augusti 2010
Avslutad studie (Faktisk)
1 augusti 2010
Studieregistreringsdatum
Först inskickad
27 augusti 2009
Först inskickad som uppfyllde QC-kriterierna
27 augusti 2009
Första postat (Uppskatta)
28 augusti 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 september 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 september 2010
Senast verifierad
1 september 2010
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Femoral vs. Psoas PNB Cath Hip
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