Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Analgesia
Intervention: morphine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): Adriana M Issy, PhD, Study Chair, Affiliation: Federal University of São Paulo
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.
Clinical Details
Official title: Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain relief
Secondary outcome: bupivacaine and morphine
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
Eligibility
Minimum age: 50 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pain Setor of Federal University of Sao Paulo, Sao Paulo, SP, Brazil
Additional Information
Starting date: June 2004
Last updated: March 11, 2008
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