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CompletedNCT04361513Updated Jun 25, 2021

Genicular Nerve Block in Rheuamtoid Arthritis

A Phase 4 interventional study of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) and triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) in Pain, Joint Function Disorder and Inflammation, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-25.

Sponsored by Sohag University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.

02

Conditions studied

  • Pain
  • Joint Function Disorder
  • Inflammation

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 64 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • RA patients
  • Age > 18
  • unilateral persistent knee arthritis

Exclusion criteria

Exclusion Criteria:

  • Participants with severe knee osteoarthritis
  • peripheral neuropathy
  • psoriatic arthritis
  • skin infection
  • or those who have allergy for Bupivacaine
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    Nerve block group

    3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.

    Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) · Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

  • Other
    intra-articular steroid injection

    1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.

    Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) · Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

Interventions

  • DrugBupivacaine hydrochloride 0.5% (Marcaine, Pfizer)

    3 point genicular nerve block

  • Drugtriamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

    intra-articular injection of triamcinilone

06

What researchers measure

Primary outcomes

  1. Pain changes by VAS

    0 means no pain and 10 means the most severe pain

    Time frame: at 0 time after 2 weeks and after 12 weeks

  2. SOLAR score for inflammation changes by ultrasound

    0 means normal and 27 means the worst possible inflammation

    Time frame: at 0 time after 2 weeks and after 12 weeks

  3. Lysholm score for change in knee function

    100 means the best performance and 0 means complete loss of function

    Time frame: at 0 time after 2 weeks and after 12 weeks

07

Study locations

1 site
  • Minia university
    Minya, 82749, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04361513
Lead sponsor
Sohag University
Responsible party
Ahmed Mahrous (Associate professor, Sohag University) — Principal investigator
First posted
Apr 24, 2020
Start date
Apr 15, 2020
Primary completion
Jul 28, 2020
Completion
Jul 28, 2020
Last update
Jun 25, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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