Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.

CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery.

The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.


Eligibility Criteria:
Inclusion Criteria:

Disease-related criteria:

* Uncomplicated and non-recurrent unilateral symptomatic inguinal hernia with a surgical indication
* Bilateral inguinal hernia symptomatic on one side and requiring surgery on the symptomatic side
* Symptomatic, normal unilateral inguino-scrotal hernia (located above the middle of the inner thigh), uncomplicated and non-recurrent, with an indication for surgery by local inguinal approach without testicular redonation.
* Open surgery with Lichtenstein's technique;
* Programmed outpatient surgery;
* Surgery performed under general anesthesia.

Population-related criteria:

* Male subjects over 18 years old;
* Subjects who have given their free informed signed consent to participate in the study;
* Subjects who are affiliated to a social security system or have rights from a social security system.

Non inclusion Criteria:

Disease-related criteria:

* Strangulated inguinal or inguino-scrotal hernia;
* Bilateral inguinal hernia symptomatic on both sides and requiring surgery on both sides
* Chronic pain state (\> 3 months) and/or long term analgesics intake susceptible to hide or interfere with pain assessment;
* Hepatic or renal failure and any other pathology that could notably extend half-life of anaesthetics and analgesics products
* Signs of infection at the surgical site;
* Severe cardiopulmonary, hepatic or renal diseases
* Active ongoing malignant disease;

Product or device-related criteria:

* Known allergy or hypersensitivity to any of the constituents of the CycloMesh (Polyethylene terephthalate + Cyclodextrin) and/or subjects allergic to ropivacaine;
* Allergy to any drugs of the anesthesia protocol;

Population-related criteria:

* Drug or alcohol abuse (addiction: i.e. chronic alcoholism or active drug addiction)
* Daily intake of level I analgesics (Paracetamol, Aspirin, Ibuprofen...etc.), for \> 6 weeks.
* Use of corticosteroids within 24 hours prior to the surgery.
* Chronic use of antidepressants, anxiolytics, neuroleptics since 1 month or more,
* In case of occasional use, taking antidepressants, anxiolytics, neuroleptics in the 72 h prior to the intervention
* Unavailability during the study
* Participation in a clinical trial within 3 months prior to the initial visit.
* Psychiatric pathology or depressive disorder