Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedMarch 14, 2008
March 1, 2008
1.1 years
March 11, 2008
March 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain relief
1 year
Secondary Outcomes (1)
bupivacaine and morphine
1 year
Study Arms (1)
A
EXPERIMENTALG1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with coagulopathy
- Infection or malignant disease
- Patients who underwent knee or hip surgery; AND
- Patients using opioids 24 hours prior to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain Setor of Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Related Publications (1)
Gazi MB, Sakata RK, Issy AM. Intra-articular morphine versus bupivacaine for knee motion among patients with osteoarthritis: randomized double-blind clinical trial. Sao Paulo Med J. 2008 Nov;126(6):309-13. doi: 10.1590/s1516-31802008000600003.
PMID: 19274316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Adriana M Issy, PhD
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 14, 2008
Study Start
June 1, 2004
Primary Completion
July 1, 2005
Study Completion
December 1, 2006
Last Updated
March 14, 2008
Record last verified: 2008-03