Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site (NCT01999153) | Clinical Trial Compass
CompletedPhase 3
Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
France58 participantsStarted 2013-12-09
Plain-language summary
The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site.
For Patient needing a thin skin graft \< 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing.
The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum
Who can participate
Age range
18 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:
* Patient older than 18 years old
* Patient needing a thin skin graft \< 320 cm2 and which is possible on the thigh
* Patient who read the information letter and signed the informed consent
* Patient affiliated at a social security system
* Effective contraceptive method for more than 3 months for women of childbearing age
Exclusion Criteria:
* Contraindication to one of the medicine used (allergy, intolerance, potential drug interaction)
* Treatment by classII or III of analgesics or analgesic dose of aspirin(\>500mg per day) at the inclusion or randomization time
* Preoperative EVA\>0 at the skin graft donor site on the thigh
* Sensory disturbances of the lower limbs
* Cognitive disturbances not allowing investigations
* Pregnant or lactating women
* People deprived of discernment
* People deprived of their liberty by judicial or administrative authority
* Protected adult (guardianship or trusteeship)
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.