Total Knee ReplacementPhase 1/2Total kneeNCT07330765
Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty
A Phase 1/2 study testing Effect of two different drugs on post operative pain after TKA in people with Total Knee Replacement, run by Abdelrahman Gaber Sayed Elkhateeb at 1 site in Egypt.
Trial summary
Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Effect of two different drugs on post operative pain after TKA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2026to 13 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients Undergoing Total Knee Replacement from 40 years old to 80 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
Read the 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.
- Conditions
- Total Knee Replacement
- Being tested
- Effect of two different drugs on post operative pain after TKA
- Keywords
- Post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of two different drugs on post operative pain after TKADrug
Also called Palmetoyelethenolamide, Placebo pill
Effect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Placebo effect on post operative pain after TKA | Experimental | 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 Receives: Drug: Effect of two different drugs on post operative pain after TKA |
| Palmetoyelethenolamide effect on post operative pain after TKA | Experimental | 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 Receives: Drug: Effect of two different drugs on post operative pain after TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease post operative pain
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
Measured: Frist 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start13 Jan 2026 (estimated)
- Primary completion13 Oct 2027 (estimated)
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Gaber Sayed Elkhateeb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Gaber Sayed Elkhateeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330765
- Sponsor's protocol ID
- Pain antieffect of PEA in TKR
- Acronym
- Total knee
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It's an experimental study it will be shared if the outcomes of the study are valid to be shared
Publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC10053226/#:~:text=Palmitoylethanolamide%20(PEA)%2C%20a%20naturally,pain%2C%20although%20this%20remains%20controversial
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
- ClinicalTrials.gov ID
- NCT07330765
- Acronym / sponsor ID
- Total knee / Pain antieffect of PEA in TKR
- Conditions
- Total Knee Replacement
- Keywords
- Post operative pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Abdelrahman Gaber Sayed ElkhateebUniversity, hospital or other
- Study start
- 13 Jan 2026 (estimated)
- Primary completion
- 13 Oct 2027 (estimated)
- Study completion
- 13 Oct 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo effect on post operative pain after TKA | Experimental | Drug: Effect of two different drugs on post operative pain after TKAThe patient will be gaven an empty pill and we will score the pain postoperative and if it has effect on postoperative pain or not |
| Palmetoyelethenolamide effect on post operative pain after TKA | Experimental | Drug: Effect of two different drugs on post operative pain after TKAThe 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients Undergoing Total Knee Replacement from 40 years old to 80 years old
Key exclusion criteria (4 listed)
- Rheumatoid Arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of two different drugs on post operative pain after TKAAlso: Palmetoyelethenolamide, Placebo pillEffect of preoperative dose of palmetoyelethenolamide in post-op pain in patient undergoing Total Knee Replacement | Drug | Palmetoyelethenolamide effect on post operative pain after TKA, Placebo effect on post operative pain after TKA |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publicationhttps://pmc.ncbi.nlm.nih.gov/articles/PMC10053226/#:~:text=Palmitoylethanolamide%20(PEA)%2C%20a%20naturally,pain%2C%20although%20this%20remains%20controversial
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It's an experimental study it will be shared if the outcomes of the study are valid to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Effect of two different drugs on post operative pain after TKA in people with Total Knee Replacement, run by Abdelrahman Gaber Sayed Elkhateeb at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Gaber Elkhareeb, Resident (201050081327, AbdElrahman.15235731@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease post operative pain (time frame: Frist 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07330765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.