Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty
Total knee
1 other identifier
interventional
1
1 country
1
Brief Summary
Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedStudy Start
First participant enrolled
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 13, 2027
January 9, 2026
December 1, 2025
1.7 years
September 27, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease post operative pain
Visual Analog Scale (VAS) will be used at 6, 12, 24 hours post-surgery for assessment of Pain. Scale from one to ten Ten means patient in sever pain One means patient is well The higher the score the pain is severer
Frist 24 hours postoperative
Study Arms (2)
Placebo effect on post operative pain after TKA
EXPERIMENTALThe patient will be gaven an empty pill and we will score the pain postoperative and if it has effect on postoperative pain or not
Palmetoyelethenolamide effect on post operative pain after TKA
EXPERIMENTALThe patient will be gaven an pill containing palmytoiethenolamide and we will score the pain postoperative and if it has effect on postoperative pain or not
Interventions
Effect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement
Eligibility Criteria
You may qualify if:
- Patients Undergoing Total Knee Replacement from 40 years old to 80 years old
You may not qualify if:
- Rheumatoid Arthritis
- History of Renal impairment
- Any complications of surgery as( iatrogenic fractures -patient with low bone quality that needs long stem prosthesis -patient with depressed tibial plateau that needs graft )
- Patients refused to be enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, Assuit, Egypt
Related Publications (1)
https://pmc.ncbi.nlm.nih.gov/articles/PMC10053226/#:~:text=Palmitoylethanolamide%20(PEA)%2C%20a%20naturally,pain%2C%20although%20this%20remains%20controversial
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
September 27, 2025
First Posted
January 9, 2026
Study Start
January 13, 2026
Primary Completion (Estimated)
October 13, 2027
Study Completion (Estimated)
October 13, 2027
Last Updated
January 9, 2026
Record last verified: 2025-12