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Completed

NCT Number: NCT01999153

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

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

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Key information

Conditions

Graft Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UHRouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

20 mL topically used during alginate dressing NAROPEINE

Drug

20 mL topically used during alginate dressing

Other names: Brand name of drug use NAROPEINE

20 mL topically used during alginate dressing NaCl

Drug

20 mL topically used during alginate dressing

Other names: NaCl 0.9 %

Primary outcomes

  1. 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

Secondary outcomes

  1. Class II antalgic consumption between the 2 arms

    Time frame: Day 90

    evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: day 90

    potential side effects of ropivacaine on the healing of skin graft donor site

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: ROPI

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2013
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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