- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00659087
Effectiveness of a Femoral Block Following Total Knee Arthroplasty (TKA)
A Pilot Study of the Feasibility of Early Discharge After Total Knee Arthroplasty Using a Femoral Nerve Block
Hospital stays after total joint replacement surgery have been getting shorter over the past 10 years. This is mostly due to new ways to manage pain and early rehabilitation. To be able to go home safely soon after surgery, patients need to:
- 1) have adequate pain control
- 2) be able to move through activities of daily living on their own (using aids)
Femoral nerve block, in combination with pain medications, is one of the new treatment strategies that are currently being used at other hospitals in Canada, the United States and the United Kingdom. Nerve blocks involve a needle filled with local anesthetic into the nerve that allows the feeling of pain around the knee. With good pain management, patients will be able to more quickly bend their knee and regain the ability to walk with aids and move from sitting and lying positions to standing and walking. Once they can do these activities with adequate pain control, they can be discharged from hospital to continue recovery at home. The purpose of this study is to examine a new way of managing postoperative pain and encourage early knee flexion and mobility, while maintaining pain control for patients after total knee replacement. We believe that patients who receive the nerve block in addition to the regular pain medication will have more knee flexion at discharge and experience less pain than patients who only receive usual pain medications.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospitals
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Undergoing primary total knee arthroplasty
- English-speaking
- Preoperative knee ROM > 90 degrees
- Body Mass Index < 40
Exclusion Criteria:
- Regular preoperative opioid use
- Hepatic insufficiency
- Any contra-indications to receiving a femoral block
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Femoral Block
Those receiving femoral block in addition to usual pain management
|
Those receiving femoral block postoperatively
|
|
Aktiv komparator: Usual Care
Those receiving only usual pain management without a femoral block
|
Those receiving only usual pain management postoperatively
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
knee flexion
Tidsramme: at hospital discharge or day 4 postoperatively, whichever is earlier
|
at hospital discharge or day 4 postoperatively, whichever is earlier
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
pain
Tidsramme: daily in hospital, 2 weeks, 6 weeks, 12 weeks
|
daily in hospital, 2 weeks, 6 weeks, 12 weeks
|
|
længde af hospitalsophold
Tidsramme: under indlæggelse
|
under indlæggelse
|
|
nausea/vomiting
Tidsramme: during hospitalization
|
during hospitalization
|
|
participation in rehabilitation
Tidsramme: day of surgery
|
day of surgery
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- J-3224
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