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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00636415
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures:
  • Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bupivacaine and morphine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Federal University of São Paulo

Additional 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
Study First Received: March 11, 2008
Last Updated: March 11, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013