The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Un… (NCT06112548) | Clinical Trial Compass
CompletedNot Applicable
The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA
Syria80 participantsStarted 2024-03-01
Plain-language summary
This interventional study aims to compare the effectiveness of local multimodal drug periarticular injection in TKA patients with the standard pain control regime that includes opioids, NSAIDs, and other analgesics.
The main questions The investigators strive to answer are:
Is there a significant difference in the severity of pain and functional outcomes when applying periarticular injections? Are there any increased complications when applying the periarticular injections?
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* all patients with end-stage arthritis of the knee going primary unilateral total knee arthroplasty.
Exclusion Criteria:
* inflammatory and secondary arthritis of the knee.
* Patients who are allergic to one or more of the drugs used in the injections.
* Patients who are already taking opioids for whatever reason or have a history of addiction.
* BMI less than 20 and more than 35.
* patients with intra-operative complications that would affect the outcomes measurement.
* Patients who are going through complex primary or revision TKA.
* Pregnancy, renal or liver failure.
* Patients who are classified as grade 3 or more according to ASA.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
perception of pain - first assessment
Timeframe: measured 12 hours after surgery.
2
perception of pain - second assessment
Timeframe: measured 24 hours after surgery.
3
perception of pain - third assessment
Timeframe: measured 48 hours after surgery.
4
functional status - first assessment
Timeframe: first measurement four weeks after surgery.
5
magnitude of disabling pain according to KSS - first assessment
Timeframe: first measurement four weeks after surgery.
6
magnitude of disabling pain according to KSS - second assessment
Timeframe: first measurement six months after surgery.
7
functional status - second assessment
Timeframe: second measurement six months after surgery.