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NCT Number: NCT07330765

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

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Assiut university

Asyut, Assuit, Egypt

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Effect of two different drugs on post operative pain after TKA

Drug

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

Other names: Palmetoyelethenolamide, Placebo pill

Primary outcomes

  1. Decrease post operative pain

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Gaber Elkhareeb, Resident

CONTACT

[email protected]

201050081327

Sponsors and collaborators

Lead sponsor

Abdelrahman Gaber Sayed Elkhateeb

Other

Registry information

Official study title

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

Acronym: Total knee

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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