- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00636415
Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial
CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis.
DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University.
METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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SP
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Sao Paulo, SP, Brasilien
- Pain Setor of Federal University of Sao Paulo
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Older than 50 years with a radiological confirmation of chronic knee osteoarthritis
- Pain lasting for more than 3 months either at rest or under strain, morning stiffness
- Absence of heat at the site
- Crepitation during movement and a pain score ranging from three to ten.
Exclusion Criteria:
- Patients with coagulopathy
- Infection or malignant disease
- Patients who underwent knee or hip surgery; AND
- Patients using opioids 24 hours prior to the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A
G1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.
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1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and 25 mg (10 ml) 0.25% bupivacaine without epinephrine.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pain relief
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
bupivacaine and morphine
Tidsramme: 1 year
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Adriana M Issy, PhD, Federal University of São Paulo
Publikationer og nyttige links
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Intra-articular morphine
- No grant
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Kliniske forsøg med morphine
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