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Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636415
First Posted: March 14, 2008
Last Update Posted: March 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • bupivacaine and morphine [ Time Frame: 1 year ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Brazil
Pain Setor of Federal University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Adriana M Issy, PhD Federal University of São Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: March 11, 2008
First Posted: March 14, 2008
Last Update Posted: March 14, 2008
Last Verified: March 2008

Keywords provided by Federal University of São Paulo:
Analgesia
Morphine
Bupivacaine
Osteoarthritis
Knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics