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CompletedNCT00636415Updated Mar 14, 2008

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

An interventional study of morphine in Analgesia, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-03-14.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Analgesia

Keywords

  • Analgesia
  • Morphine
  • Bupivacaine
  • Osteoarthritis
  • Knee
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's enrollment of 30 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.

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Lead sponsor

Federal University of São Paulo is the lead sponsor of 438 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    A

    G1 patients received morphine intra-articular route G2 patients received bupivacaine without epinephrine.

    Drug: morphine

Interventions

  • 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.

    Also known as: dimorf

06

What researchers measure

Primary outcomes

  1. Pain relief

    Time frame: 1 year

Secondary outcomes

  1. bupivacaine and morphine

    Time frame: 1 year

07

Study locations

1 site
  • Pain Setor of Federal University of Sao Paulo
    São Paulo, São Paulo, Brazil
08

References and documents

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. doi: 10.1590/s1516-31802008000600003. PubMed 19274316 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00636415
First posted
Mar 14, 2008
Start date
Jun 2004
Primary completion
Jul 2005
Completion
Dec 2006
Last update
Mar 14, 2008

Study contacts

Adriana M Issy, PhD
study chair · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Morphine

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