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临床试验/NCT06121726
NCT06121726已完成不适用

Evaluation of Predictive Factors for the Effectiveness of the Ilioinguinal Iliohypogastric Nerve Block in Unilateral Inguinal Hernioplasty

University of Padova1 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2023年10月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
343
试验地点
1
主要终点
ilioinguinal-iliohypogastric nerve block failure

研究概览

简要总结

Inguinal hernia repair is a common surgical procedure done as day surgery. Because patients need to be discharged on the same day, the choice of anesthesia technique is influenced. One option is the ilioinguinal (II)-iliohypogastric (IH) nerve block, a type of transversus abdominis plane (TAP) block, which has benefits such as faster recovery, better pain control, and reduced opioid use. It also allows for quick discharge, early feeding, and no need for post-anesthesia or recovery unit stay.

This study aims to evaluate the success of the II-IH nerve block as the preferred anesthesia strategy for patients undergoing unilateral inguinal hernia repair using the Lichtenstein technique. The study will analyze various factors such as BMI, age, optimal ultrasound vision, amount of anesthesia used, dose of anesthesia administered, time between block execution and incision, and sedative dose needed to determine independent variables of block effectiveness.

The study will include patients aged 18 or older, with ASA I-II-III classification, and who provide informed consent. Patients with allergies to local anesthetics, certain medical conditions, obesity, difficulty visualizing target structures, non-cooperative behavior, or taking anticoagulant therapy will be excluded.

The study will be conducted at the Sant'Antonio Hospital (Padova University Hospital) operating rooms for one year, aiming to recruit around 400 patients.

Informed consent for data processing will be obtained during the preoperative anesthesia visit, and standard anesthesia procedures will be followed during the surgery.

As usual care the patient will be monitored before surgery using an electrocardiogram, oxygen saturation measurement, and non-invasive blood pressure. After adequate sedation, the II-IH nerve block will be performed under sterile conditions and ultrasound guidance.

Participation in the study does not modify the commonly used anesthesia procedures and does not pose any additional risks or provide direct benefits to the patients. The data collected will be treated confidentially and used exclusively for the study's purposes.

Data collection will be conducted through a paper-based form, and only a few variables will be recorded. The study's findings will be made public, even if negative, and will be submitted to the ethics committee within twelve months of data collection completion.

详细描述

Inguinal hernioplasty is one of the most commonly performed surgical procedures in day surgery. The need to discharge the surgical patient on the same day affects the choice of anesthetic strategy and leads to opt for those techniques that allow for faster recovery. One option is represented by the ilioinguinal (II)-iliohypogastric (IH) nerve block, a variant of the transversus abdominis plane (TAP) block, which has a safety profile, ease of execution, effectiveness in controlling intra- and post-operative pain, with a reduction in opioid administration and increased patient satisfaction. It also has additional advantages, such as rapid patient discharge, early refeeding, no need for post-anesthesia care unit (PACU) or recovery room admission.

It is not yet established what the success rate of the anesthetic block is, intended as the absence of the need for further infiltration by the surgeon, the administration of opioid drugs, or the need to convert to general anesthesia, nor what the independent risk factors are for the positive outcome of the procedure. The aim of this study is therefore to evaluate the success of the ilioinguinal-iliohypogastric block as the anesthetic strategy of choice in patients undergoing unilateral inguinal hernioplasty with the Lichtenstein technique, and the independent variables of block effectiveness, analyzing various parameters such as BMI, age, optimal ultrasound visualization, volume of anesthetic used, dose of anesthetic administered, time elapsed between the execution of the II-IH block and the incision, and the necessary dose of sedative drugs.

All patients who need to undergo unilateral inguinal hernioplasty according to the Lichtenstein technique, aged ≥ 18 years, American Society of Anesthesiology-Physical Status (ASA-PS) I-II-III, and who give their informed consent to participate in the study will be recruited. Patients with allergies to local anesthetics; heart disease, kidney disease, liver disease, uncompensated central or peripheral neuropathy; history of coagulopathy (risk/benefit ratio to be evaluated); infection at the site of the procedure; obesity (high BMI) or difficulty in visualizing target structures will be excluded. Non-cooperative patients or those taking anticoagulant therapy will also not be included.

This observational, prospective, monocentric study will be conducted in the operating rooms of the Sant'Antonio Hospital (Hospital-University Company of Padova) and will last for one year. An attempt will be made to recruit the largest number of patients within this time frame, and considering the surgical activity at the operating facility, it is estimated that approximately 400 patients will be enrolled.

The patient will be recruited after verifying the inclusion/exclusion criteria. Each patient will be informed about the study and asked for written informed consent for the treatment of personal data at the time of the standard preoperative anesthesiology visit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ilioinguinal-Iliohypogastric nerve block

Patients will receive Ilioinguinal-Iliohypogastric nerve block as standard of care

干预措施: Ilioinguinal-Iliohypogastric nerve block (Other)

Ilioinguinal-Iliohypogastric nerve block

Patients will receive Ilioinguinal-Iliohypogastric nerve block as standard of care

干预措施: Local anesthetic (Drug)

结局指标

主要结局

ilioinguinal-iliohypogastric nerve block failure

时间窗: through surgery completation, an average of 1 hour

Described as the need of additional local anesthetic, additional opioids and/or general anesthesia

次要结局

  • Ultrasound Nerves Visualization (yes/no) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure(through surgery completation, an average of 1 hour)
  • Total body weight (kg) as predictive parameter for ilioinguinal-iliohypogastric nerve block failure(through surgery completation, an average of 1 hour)
  • Dose of anesthetic(mg) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure(through surgery completation, an average of 1 hour)
  • Time From Block To Skin Incision(minutes) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure(through surgery completation, an average of 1 hour)
  • Local anesthetic volume(mL) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure(through surgery completation, an average of 1 hour)
  • Age(years) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure(through surgery completation, an average of 1 hour)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro De Cassai

MD

University of Padova

研究点 (1)

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