Assiut university
Asyut, Assuit, Egypt
NCT Number: NCT07330765
Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
Trial opening soon.
Get Notified40 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Asyut, Assuit, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients Undergoing Total Knee Replacement from 40 years old to 80 years old
Exclusion criteria
Effect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement
Other names: Palmetoyelethenolamide, Placebo pill
Time frame: Frist 24 hours postoperative
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
Contact information is provided by the study sponsor or research team.
Abdelrahman Gaber Sayed Elkhateeb
Other
Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
Acronym: Total knee
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