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

Abdelrahman Gaber Sayed Elkhateeb

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Total Knee Replacement

Treatments: Drug: Effect of two different drugs on post operative pain after TKA

Study type: Interventional

Funder types: Other

Identifiers

NCT07330765

Pain antieffect of PEA in TKR

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 estimated patient

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Placebo effect on post operative pain after TKA

Experimental group

Description:

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

Treatment:

Drug: Effect of two different drugs on post operative pain after TKA

Palmetoyelethenolamide effect on post operative pain after TKA

Experimental group

Description:

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

Treatment:

Drug: Effect of two different drugs on post operative pain after TKA