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

Graft Pain Clinical Trial

— ROPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999153
• Other study ID #: 2012/119/HP
• Status: Recruiting
• Phase: Phase 3
• First received: July 29, 2013
• Last updated: June 13, 2017
• Start date: December 2013
• Est. completion date: May 2018

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: Dorothée COQUEREL, MD
• Phone: +33232888760
• Email: dorothee.coquerel-beghin[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Graft Pain

Intervention

Drug:
• 20 mL topically used during alginate dressing NAROPEINE
20 mL topically used during alginate dressing
• 20 mL topically used during alginate dressing NaCl
20 mL topically used during alginate dressing

Locations

Country	Name	City	State
France	UHRouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Class II antalgic consumption between the 2 arms	evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site	Day 90
Secondary	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