Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 11, 2008 | ||||
| Last Updated Date | March 11, 2008 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
bupivacaine and morphine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis | ||||
| Official Title ICMJE | Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial | ||||
| 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. |
||||
| Detailed Description | 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 |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Analgesia | ||||
| Intervention ICMJE | 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 |
||||
| Study Arm (s) | Experimental: A
G1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.
Intervention: Drug: morphine |
||||
| Publications * | 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 ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 50 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00636415 | ||||
| Other Study ID Numbers ICMJE | Intra-articular morphine, No grant | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Adriana Machado Issy/ Professor, Federal University of São Paulo | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | March 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||