Skip to content

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.

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07330765
Acronym
Total knee
Enrollment
1
Registered
2026-01-09
Start date
2026-01-13
Completion date
2027-10-13
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

Keywords

Post operative pain

Brief summary

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

DRUGEffect 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

Sponsors

Abdelrahman Gaber Sayed Elkhateeb
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease post operative painFrist 24 hours postoperativeVisual 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

Countries

Egypt

Contacts

Primary ContactAbdelrahman Gaber Elkhareeb, Resident
AbdElrahman.15235731@med.aun.edu.eg201050081327

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026