Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site (ROPI)

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 Overview

• Status: Completed
• Conditions: Graft Pain
• Intervention / Treatment: Drug: 20 mL topically used during alginate dressing NAROPEINE; Drug: 20 mL topically used during alginate dressing NaCl

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • UHRouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DRUG : ROPIVACAINE; 20 mL topically used during alginate dressing	Drug: 20 mL topically used during alginate dressing NAROPEINE; 20 mL topically used during alginate dressing; Other Names: Brand name of drug use NAROPEINE
Placebo Comparator: PLACEBO : NaCl 0.9 %; 20 mL topically used during alginate dressing	Drug: 20 mL topically used during alginate dressing NaCl; 20 mL topically used during alginate dressing; Other Names: NaCl 0.9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Class II antalgic consumption between the 2 arms	evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site	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	day 90

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Dorothée COQUEREL-BEGHIN, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2013
• Primary Completion (Actual): October 4, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: July 29, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimated): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: donor site; skin graft
• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: 2012/119/HP