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Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
This study has been completed.
Study NCT00636415   Information provided by Federal University of São Paulo
First Received: March 11, 2008   No Changes Posted

March 11, 2008
March 11, 2008
June 2004
July 2005   (final data collection date for primary outcome measure)
Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
bupivacaine and morphine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
 
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.

Among the 39 patients selected, two patients from group 1 and five from group 2 were excluded from some of the analyses because they did not return on the day of assessment or because they used a complementary analgesic different from that standardized in the study

 
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Analgesia
Drug: morphine
Experimental: G1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
December 2006
July 2005   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00636415
Adriana Machado Issy/ Professor, Federal University of São Paulo
Intra-articular morphine, No grant
Federal University of São Paulo
 
Study Chair: Adriana M Issy, PhD Federal University of São Paulo
Federal University of São Paulo
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP