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NCT Number: NCT00636415

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

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.

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Key information

Conditions

Analgesia Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Setor of Federal University of Sao Paulo

São Paulo, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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 names: dimorf

Primary outcomes

  1. Pain relief

    Time frame: 1 year

Secondary outcomes

  1. bupivacaine and morphine

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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