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

Quanta Medical304 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

304

Conditions

Inguinal Hernia

Interventions

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

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).

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.

Time frame: 6 hours post-surgery

Secondary Outcomes

Pain intensity back to home (Day 0) and Day 1 to 3 will be assessed using a Visual Analogic Scale (VAS)

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

Time frame: 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 at Day 1 and Day 7 post-surgery will be assessed using a Visual Analogic Scale (VAS)

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.

Time frame: Day 1 and Day 7 post-surgery

Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS)

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.

Time frame: 1 month post-surgery

Hospitalization lenght (in hours)

In case of delayed discharge (the day after the surgery or prolongation of hospitalization), the reasons of prolonged hospital treatment will be collected

Time frame: 1 week post-surgery

Duration of surgical time from the first incision until wound closure (in minutes)

Duration of surgical time from the first incision until wound closure will be calculated in minutes

Time frame: At the moment of wound closure

Evolution between inclusion and 24 months post-surgery with regard to quality of life

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

Time frame: Inclusion and 1 month post-surgery 12 and 24 months post-surgery

The amount of consumed analgesic will be assessed using post-operative data and data reported by the patient on a log book

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 frame: 7 days post-surgery period

Time to return to work or activity 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

Time frame: Day 1, Day 7 and 1 month post-surgery

The rate of early recurrence (at 1 month postoperative) and at long term (12 and 24 months) will be assessed

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.