Interventional Study of Antalgic Efficacy of the CycloMesh™ Implant Soaked in Ropivacaine Hydrochloride 10 Mg/mL in the Treatment of Uncomplicated Inguinal Hernia. Randomized Comparative Study Versus CycloMesh™ Soaked in Physiological Saline Solution NaCl 9°/°°
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
时间窗: 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.
次要结局
- Time to return to work or activity post-surgery(Day 1, Day 7 and 1 month post-surgery)
- Satisfaction of the surgeon and unit staff regarding the use of CycloMesh will be evaluated using a satisfaction questionnaire(Day 0)
- Number of patients presenting at least one AE related to the the device implantation(All study period (24-months))
- Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS)(1 month post-surgery)
- Number of patients presenting at least one serious adverse event (SAE)(All study period (24-months))
- 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)
- Duration of surgical time from the first incision until wound closure (in minutes)(At the moment of wound closure)
- 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)
- 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)
- Hospitalization lenght (in hours)(1 week post-surgery)
- 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)
- Number of patients presenting at least one adverse event (AE)(All study period (24-months))
- 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))
- Total number of AE related to the device implantation, classified by type and organ(All study period (24-months))
- 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 rate of patient with chronic pain at 12 and 24 months(12-months after surgery and 24-months after surgery)
- The rate of implant migration at 12 and 24 months(12-months after surgery and 24-months after surgery)
- The rate of foreign body sensation at 12 and 24 months postoperative(12-months after surgery and 24-months after surgery)