Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative… (NCT03493490) | Clinical Trial Compass
CompletedPhase 4
Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery
Austria72 participantsStarted 2018-03-01
Plain-language summary
The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.
Who can participate
Age range
18 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:
* Elective cruciate ligament surgery
* Confirmed patient suitability for planned surgery
* Legally valid signed written informed consent provided
* Female patients are confirmed non-pregnant (negative pregnancy test) or not breast feeding
* Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients
* No known intolerabilities or hypersensitivities to any part of the IMP / control medication
* No reoperation/revision within 6 months after the initial surgery
* Absence of history of abuse of analgesics or other drug
* No analgesics within 48 hours prior to surgery (surgery-related medication excluded)
* No current / recent (within 4 weeks prior to enrolment) experimental treatment
* No current / recent (within 4 weeks prior to enrolment) participation in another clinical study
* No foreseeable difficulties with regard to protocol compliance
* No known hypersensibility against the active ingredients diclofenac, orphenadrine, remifentanil, propofol, rocuronium, and hydromorphone
* No known hypersensibility against the other ingredients of the investigational medicinal product
* Absence of congestive heart failure classes 2 or higher according to the NYHA classification
* Absence of ischemic heart disease
* Absence of peripheral arterial occlusive disease
* Absence of cerebro-vascular disease
* Absence of significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemi…
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
PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg