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| Sponsor: | Federal University of São Paulo |
|---|---|
| Information provided by: | Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT00636415 |
Purpose
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 | Intervention |
|---|---|
|
Analgesia |
Drug: morphine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial |
| Enrollment: | 30 |
| Study Start Date: | June 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
G1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.
|
Drug: morphine
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
|
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
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Adriana Machado Issy/ Professor, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT00636415 History of Changes |
| Other Study ID Numbers: | Intra-articular morphine, No grant |
| Study First Received: | March 11, 2008 |
| Last Updated: | March 11, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
Analgesia Morphine Bupivacaine Osteoarthritis Knee |
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Bupivacaine Morphine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Analgesics Narcotics |
