Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-13

Study Completion Date

2027-10-13

Brief Summary

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Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.

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Detailed Description

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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.

Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo effect on post operative pain after TKA

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

Group Type EXPERIMENTAL

Effect of two different drugs on post operative pain after TKA

Intervention Type DRUG

Effect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement

Palmetoyelethenolamide effect 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

Group Type EXPERIMENTAL

Effect of two different drugs on post operative pain after TKA

Intervention Type DRUG

Effect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Palmetoyelethenolamide Placebo pill

Eligibility Criteria

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Inclusion Criteria

Patients Undergoing Total Knee Replacement from 40 years old to 80 years old

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes