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

NCT04033055 | Completed DMC

• 1 other identifier: 2891
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours post-surgery

Secondary Outcomes (18)

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

  1 month post-surgery

• Hospitalization lenght (in hours)

  1 week post-surgery

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

  At the moment of wound closure

Study Arms (2)

CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL

EXPERIMENTAL

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.

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

CycloMesh™ soaked in saline solution 9°/°°

ACTIVE COMPARATOR

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.

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

Interventions

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.

CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL

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.

CycloMesh™ soaked in saline solution 9°/°°

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Quanta Medical: lead
• Cousin Biotech: collaborator

Study Sites (1)

Amiens Picardie university hospital

Amiens, 80054, France

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded to the randomisation arm. As the procedure is conducted under general anaesthesia, the patient will not be informed whether the procedure which was performed on him/her did or did not result in the implantation of the CycloMesh™ device. Also, the surgeon such as the outcome assessor will be blinded to the randomisation arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 25, 2019
• Study Start: October 31, 2019
• Primary Completion: March 16, 2022
• Study Completion: March 12, 2024
• Last Updated: March 20, 2025

Record last verified: 2024-03

Locations

FR (1)