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

NCT ID: NCT01999153

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-09
• Study Completion Date: 2018-10-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DRUG : ROPIVACAINE

20 mL topically used during alginate dressing

Group Type: EXPERIMENTAL

20 mL topically used during alginate dressing NAROPEINE

Intervention Type: DRUG

20 mL topically used during alginate dressing

PLACEBO : NaCl 0.9 %

20 mL topically used during alginate dressing

Group Type: PLACEBO_COMPARATOR

20 mL topically used during alginate dressing NaCl

Intervention Type: DRUG

20 mL topically used during alginate dressing

Interventions

20 mL topically used during alginate dressing NAROPEINE

20 mL topically used during alginate dressing

Intervention Type: DRUG

20 mL topically used during alginate dressing NaCl

20 mL topically used during alginate dressing

Intervention Type: DRUG

Other Intervention Names

Brand name of drug use NAROPEINE; NaCl 0.9 %

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothée COQUEREL-BEGHIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

UHRouen

Rouen, , France

Countries

France

Other Identifiers

2012/119/HP

Identifier Type: -

Identifier Source: org_study_id