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

NCT01999153 | Completed Phase 3

• 1 other identifier: 2012/119/HP
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Graft Pain

Keywords

skin graft; donor site

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Class II antalgic consumption between the 2 arms

  Day 90

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

  day 90

Study Arms (2)

DRUG : ROPIVACAINE

EXPERIMENTAL

20 mL topically used during alginate dressing

Drug: 20 mL topically used during alginate dressing NAROPEINE

PLACEBO : NaCl 0.9 %

PLACEBO COMPARATOR

20 mL topically used during alginate dressing

Drug: 20 mL topically used during alginate dressing NaCl

Interventions

20 mL topically used during alginate dressing NAROPEINE DRUG

20 mL topically used during alginate dressing

Also known as: Brand name of drug use NAROPEINE

DRUG : ROPIVACAINE

20 mL topically used during alginate dressing NaCl DRUG

20 mL topically used during alginate dressing

Also known as: NaCl 0.9 %

PLACEBO : NaCl 0.9 %

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to one of the medicine used (allergy, intolerance, potential drug interaction)
• 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)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UHRouen

Rouen, 76031, France

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dorothée COQUEREL-BEGHIN, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: December 3, 2013
• Study Start: December 9, 2013
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

FR (1)