A Phase 1/2 interventional study of Effect of two different drugs on post operative pain after TKA in Total Knee Replacement, sponsored by Abdelrahman Gaber Sayed Elkhateeb. Not yet recruiting at 1 site in Egypt. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Abdelrahman Gaber Sayed Elkhateeb · Phase 1/2, Interventional, and Treatment
Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
Elective total knee arthroplasty (TKA) is the gold standard for management of arthritis-associated pain and disability in osteoarthritis patients who have failed non-operative treatment modalities Following TKA, patients experience severe pain mediated by multiple pathways Painful stimuli to the body are detected by the free endings of peripheral nerves called nociceptors . Pre-emptive analgesia is analgesia given before the onset of painful stimuli to prevent central sensitization of nervous system to subsequent stimuli that could increase pain Studies have shown that pre-emptive analgesia reduce immediate postoperative pain and also prevent the development of chronic pain by decreasing altered sensory processing .
Multi-modal analgesia is the rational approach to pain management since no single analgesia targets all types of pain
. Increasing evidence has shown that neuro-inflammation plays a key role in pain progression which is sustained by an imbalance within pro-inflammatory and pro-resolving mediators Acylethanolamines (NAEs) are a family of endogenous bio active lipids that regulate multiple processes including pain and inflammation . One of the most widely studied NAEs is the analgesic endocannabinoid compound, palmitoylethanolamide (PEA). Previous research has demonstrated the effectiveness of PEA on conditions characterized by chronic and/or neurological pain The aim of the study is to investigate the safety, tolerability and efficacy of doses of PEA on symptoms of post operative pain.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 1 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Abdelrahman Gaber Sayed Elkhateeb as lead sponsor.
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Patients Undergoing Total Knee Replacement from 40 years old to 80 years old
Exclusion Criteria
Rheumatoid Arthritis
The patient will be gaven an empty pill and we will score the pain postoperative and if it has effect on postoperative pain or not
Drug: Effect of two different drugs on post operative pain after TKA
The 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
Drug: Effect of two different drugs on post operative pain after TKA
Effect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement
Also known as: Palmetoyelethenolamide, Placebo pill
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
Time frame: Frist 24 hours postoperative
Plan to share: Undecided — It's an experimental study it will be shared if the outcomes of the study are valid to be shared
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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