antalgic efficacy of cyclomesh™ soaked in ropivacaine hydrochloride in uncomplicated inguinal hernia.

Conditions: Inguinal Hernia

Summary: 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