Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT00636415|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : March 14, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Analgesia||Drug: morphine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||December 2006|
G1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.
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.
Other Name: dimorf
- Pain relief [ Time Frame: 1 year ]
- bupivacaine and morphine [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636415
|Pain Setor of Federal University of Sao Paulo|
|Sao Paulo, SP, Brazil|
|Study Chair:||Adriana M Issy, PhD||Federal University of São Paulo|