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Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
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.
Age
40 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Assiut university
Asyut, Assuit, Egypt
Start Date
January 13, 2026
Primary Completion Date
October 13, 2027
Completion Date
October 13, 2027
Last Updated
January 9, 2026
1
ESTIMATED participants
Effect of two different drugs on post operative pain after TKA
DRUG
Lead Sponsor
Abdelrahman Gaber Sayed Elkhateeb
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05642260