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

Phase 3

• Conditions: Graft Pain
• Interventions: Drug: 20 mL topically used during alginate dressing NaCl; Drug: 20 mL topically used during alginate dressing NAROPEINE

• Registration Number: NCT01999153
• Lead Sponsor: University Hospital, Rouen

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-29
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO : NaCl 0.9 %	20 mL topically used during alginate dressing NaCl	20 mL topically used during alginate dressing
DRUG : ROPIVACAINE	20 mL topically used during alginate dressing NAROPEINE	20 mL topically used during alginate dressing

Primary Outcome Measures

Name	Time	Method
Class II analgesic consumption between the 2 arms	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 Outcome Measures

Name	Time	Method
Class II antalgic consumption between the 2 arms	Day 90	evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	day 90	potential side effects of ropivacaine on the healing of skin graft donor site

Trial Locations

Locations (1)

UHRouen; 🇫🇷 Rouen, France