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

• Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL (Procedure): The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed.
• Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°° (Procedure): The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed.

Primary outcomes

• Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS). [6 hours post-surgery]: The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations. Pain assessment will be performed 6 hours after implant placement and during cough effort.

Secondary outcomes

• Pain intensity back to home (Day 0) and Day 1 to 3 will be assessed using a Visual Analogic Scale (VAS) [Back to home (Day 0) at 8pm and 10 pm, Twice a day (8 am and 8 pm) at Day 1, Day 2 and Day 3]: Pain intensity will be reported by the patient on a log book using a Visual Analogic Scale . The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate
• Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a Visual Analogic Scale (VAS) [Day 1 and Day 7 post-surgery]: Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a visual analogic scale and during a telephone interview performed by an investigator's collaborator. The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate.It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations.
• Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS) [1 month post-surgery]: Pain intensity at 1 month post-surgery will be assessed, using a visual analogic scale, during a visit to the surgeon and in 3 different situations: at rest, walking and during cough effort.The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate.It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations.
• Hospitalization lenght (in hours) [1 week post-surgery]: In case of delayed discharge (the day after the surgery or prolongation of hospitalization), the reasons of prolonged hospital treatment will be collected
• Duration of surgical time from the first incision until wound closure (in minutes) [At the moment of wound closure]: Duration of surgical time from the first incision until wound closure will be calculated in minutes
• Evolution between inclusion and 24 months post-surgery with regard to quality of life [Inclusion and 1 month post-surgery 12 and 24 months post-surgery]: Quality of life will be assessed using the 36-item Short Form Health Survey (SF-36) score at inclusion and 1 month post-surgery: SF-36 is a standardized and validated questionnaire assessing quality of life. The SF-36 provides two scores: a mental and social quality of life score and a physical quality of life score
• The amount of consumed analgesic will be assessed using post-operative data and data reported by the patient on a log book [7 days post-surgery period]: The amount of consumed analgesic will be measured by calculating the number of patients who have consumed analgesic during the 7 post-operative and antalgic intake (in mg) during the 7 post-operative
• Time to return to work or activity post-surgery [Day 1, Day 7 and 1 month post-surgery]: The Time to return to work or activity following surgery will be evaluated in terms of the number of days between hospitalisation and resumption of activity
• The rate of early recurrence (at 1 month postoperative) and at long term (12 and 24 months) will be assessed [All study period (24-months)]: Rates of early reccurence during the study (up to one month after surgery). The long-term recurrence rate will also be assessed at 12 and 24 months post-operatively. Recurrence is defined as the reappearance of the hernia on the same side as the one initially operated on, whether the recurrence required surgical intervention.
• Number of patients presenting at least one adverse event (AE) [All study period (24-months)]: The safety and tolerability end points will be will be as follows: number of patients presenting at least one adverse event (AE)
• Number of patients presenting at least one AE related to the the device implantation [All study period (24-months)]: The safety and tolerability end points will be will be as follows: number of patients presenting at least one AE related to the the device implantation
• Number of patients presenting at least one serious adverse event (SAE) [All study period (24-months)]: The safety and tolerability end points will be will be as follows: number of patients presenting at least one serious adverse event (SAE)
• Total number of AE related to the device implantation, classified by type and organ [All study period (24-months)]: The safety and tolerability end points will be will be as follows: total number of AE related to the device implantation, classified by type and organ
• Satisfaction of the surgeon and unit staff regarding the use of CycloMesh will be evaluated using a satisfaction questionnaire [Day 0]: Surgeon and unit staff will have to answer to a questionnaire concerning the packaging of CycloMesh, the technical characteristics of the implant (flexibility, porosity, etc.), its size, time imbibition of CycloMesh, etc.
• Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS). [6 hours post-surgery]: The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations. Pain assessment will be performed 6 hours after implant placement at rest and walking
• The rate of patient with chronic pain at 12 and 24 months [12-months after surgery and 24-months after surgery]: Chronic pain is defined as pain that lasts for at least 6 months after surgery
• The rate of implant migration at 12 and 24 months [12-months after surgery and 24-months after surgery]: Migration is defined as the movement of the entire implant into an organ.
• The rate of foreign body sensation at 12 and 24 months postoperative [12-months after surgery and 24-months after surgery]: Foreign body sensation is assessed by answering yes or no to the question: do you feel a foreign body in the groin

Sex: Male, ages: 18 Years to any

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