Menu
Not yet recruiting NCT07330765

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

Phase I / Phase II Interventional Total Knee Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Effect of two different drugs on post operative pain after TKA.
Who it may be relevant to
Registry conditions: Total Knee Replacement. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • 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

Primary outcome measures

  • Decrease post operative pain [Time frame: Frist 24 hours postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut university — Asyut

Publications

  • https://pmc.ncbi.nlm.nih.gov/articles/PMC10053226/#:~:text=Palmitoylethanolamide%20(PEA)%2C%20a%20naturally,pain%2C%20although%20this%20remains%20controversial

Identifiers

NCT: NCT07330765 · Pain antieffect of PEA in TKR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗