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

Quanta Medical

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL; Procedure: Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°

Study type: Interventional

Funder types: Industry

Identifiers

NCT04033055

2891

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 2 patient groups

CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL

Experimental group

Description:

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.

Treatment:

Procedure: Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL

CycloMesh™ soaked in saline solution 9°/°°

Active Comparator group

Description:

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.

Treatment:

Procedure: Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°