Graft PainPhase 3ROPINCT01999153
Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
A Phase 3 study testing 20 mL topically used during alginate dressing NAROPEINE and 20 mL topically used during alginate dressing NaCl in people with Graft Pain, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Pain
- What is being tested?
- 20 mL topically used during alginate dressing NAROPEINE and 20 mL topically used during alginate dressing NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2013to 4 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- People deprived of discernment
- People deprived of their liberty by judicial or administrative authority
- Protected adult (guardianship or trusteeship)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Graft Pain
- Being tested
- 20 mL topically used during alginate dressing NAROPEINE, 20 mL topically used during alginate dressing NaCl
- Keywords
- skin graft, donor site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mL topically used during alginate dressing NAROPEINEDrug
Also called Brand name of drug use NAROPEINE
20 mL topically used during alginate dressing
20 mL topically used during alginate dressing NaClDrug
Also called NaCl 0.9 %
20 mL topically used during alginate dressing
| Study group | Role | What they receive |
|---|---|---|
| DRUG : ROPIVACAINE | Experimental | 20 mL topically used during alginate dressing Receives: Drug: 20 mL topically used during alginate dressing NAROPEINE |
| PLACEBO : NaCl 0.9 % | Placebo comparator | 20 mL topically used during alginate dressing Receives: Drug: 20 mL topically used during alginate dressing NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Class II analgesic consumption between the 2 arms
Evaluate the effect of ropivacaine in topical use on an alginate dressing by evaluating the use of class II analgesic medicines in patient who had a thin skin graft
Measured: 5 days post-operative
Secondary outcomes (2)
Class II antalgic consumption between the 2 arms
evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site
Measured: Day 90
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
potential side effects of ropivacaine on the healing of skin graft donor site
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study start9 Dec 2013
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft PainStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothée COQUEREL-BEGHIN, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999153
- Sponsor's protocol ID
- 2012/119/HP
- Acronym
- ROPI
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2013
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
- ClinicalTrials.gov ID
- NCT01999153
- Acronym / sponsor ID
- ROPI / 2012/119/HP
- Conditions
- Graft Pain
- Keywords
- skin graft, donor site
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Dec 2013 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 3 Dec 2013 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRUG : ROPIVACAINE | Experimental | Drug: 20 mL topically used during alginate dressing NAROPEINE20 mL topically used during alginate dressing |
| PLACEBO : NaCl 0.9 % | Placebo comparator | Drug: 20 mL topically used during alginate dressing NaCl20 mL topically used during alginate dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| 20 mL topically used during alginate dressing NAROPEINEAlso: Brand name of drug use NAROPEINE20 mL topically used during alginate dressing | Drug | DRUG : ROPIVACAINE |
| 20 mL topically used during alginate dressing NaClAlso: NaCl 0.9 %20 mL topically used during alginate dressing | Drug | PLACEBO : NaCl 0.9 % |
Primary outcome
Class II analgesic consumption between the 2 arms
Time frame: 5 days post-operative
Evaluate the effect of ropivacaine in topical use on an alginate dressing by evaluating the use of class II analgesic medicines in patient who had a thin skin graft
2 secondary outcomes
Class II antalgic consumption between the 2 arms
Time frame: Day 90
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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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. This study is not recruiting at the moment.
Dorothée COQUEREL-BEGHIN, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 20 mL topically used during alginate dressing NAROPEINE and 20 mL topically used during alginate dressing NaCl in people with Graft Pain, run by University Hospital, Rouen at 1 site in France.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 22 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Class II analgesic consumption between the 2 arms (time frame: 5 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.