跳至主要内容
临床试验/NCT01625780
NCT01625780终止不适用

A New Approach to Ilio-inguinal Nerve Blocks: 3-layer Injection vs Conventional Ultrasound-guided Single-shot Approach

University of Alberta2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
32
试验地点
2
主要终点
Time to completion of block for equal analgesia (intraoperative or post-operative need for rescue analgesia)

研究概览

简要总结

Ilio-inguinal nerve blocks have a long history of efficacy in treatment of post-operative pain following inguinal surgery. Several anatomic studies have shown that the nerves supplying the inguinal area have a certain degree of variability with respect to their location between the internal and external oblique layers of the anterior abdominal wall. Furthermore, the standard single-shot approach to ilio-inguinal nerve blocks has a significant incidence of unintended femoral nerve block, which can impair patients' ability to walk after surgery. The investigators are proposing a new approach to the ilio-inguinal nerve block, which divides the total dose of local anesthetic into 3 equal parts, injecting each 1/3 into different layers of the anterior abdominal wall and sub-cutaneously. The investigators intend to show that this new technique, the Tsui approach, provides equal analgesia to the standard single-shot ultrasound-guided ilio-inguinal nerve block, while being faster to perform and having a lower incidence of unintended femoral nerve blockade. Patients under age 10 who are scheduled for elective inguinal surgery (hydrocele repair, orchidopexy, and inguinal hernia repair), who have already consented to an ilio-inguinal nerve block that is commonly placed for this type of procedure, will be approached to participate in this study. No increased risk is anticipated for these patients, as both ultrasound-guided and blind techniques are equally well-accepted in the literature for this type of block, and in addition there are few vascular or neural structures in this anatomical area (just medial and inferior to the anterior superior iliac spine) that may be damaged. Follow-up will be limited to an assessment of pain scores in the PACU post-operatively and any unintended femoral nerve blockade in post-PACU. This will not delay their hospital discharge as these are same-day surgery patients.

详细描述

Project Summary Rationale - The conventional technique for performing an ilio-inguinal nerve block involves a single shot of local anesthetic (usually 0.3 mL/kg of 0.25% bupivacaine) in the transversus abdominis plane of the anterior abdominal wall. Using a blind technique (also known as "fascial click"), a blunted needle (20 gauge) is placed 1 cm medial and 1 cm inferior to the anterior superior iliac spine (ASIS), and directed downward perpendicular to the skin surface until two distinct "pops" are felt, corresponding to the external and internal oblique fascial layers. The entire volume of local anesthetic is then deposited in this plane. Success with this technique ranges from 35-75% in the literature (1-3). Studies have shown that volumes as low as 0.075 mL/kg of 0.25% levobupivacaine have provided equal analgesia to 0.2 mL/kg for up to 4 hours post-operatively when ultrasound guidance is used to ensure placement of local anesthetic near the ilio-inguinal and/or ilio-hypogastric nerves (4), resulting in a 100% success rate for this block.

We are proposing a technique that will deliver 1/3 of the total dose of local anesthetic (0.3 mL/kg of 0.25% bupivacaine) for each layer of the lower anterior abdominal wall. Due to the anatomic variability of the course of the ilio-inguinal and ilio-hypogastric nerves, we believe that the placement of 0.1 mL/kg in each of the external oblique, internal oblique, and transversus abdominis layers will improve the success of the "fascial click" approach without the need for ultrasound guidance. In addition, the ilio-inguinal nerve block has a known complication of unintended femoral nerve block. The incidence of femoral nerve block varies from 4.5% to 9% (5); in fact, one randomized controlled trial of ilio-inguinal nerve block for inguinal hernia repair in adults had to be stopped prior to completion due to patient harm (falls, etc) from femoral nerve blockade (6). We propose that a 3-layer technique will have a lower incidence of unintended femoral nerve block as compared to the conventional single-shot technique.

For inguinal surgery (orchidopexy, inguinal hernia repair, or hydrocele repair), both the ilio-inguinal and ilio-hypogastric nerves need to be blocked. The ilio-inguinal nerve arises from L1 and follows the inguinal canal to innervate the medial aspect of the thigh, anterior scrotum or labia. The ilio-hypogastric nerve has an anterior cutaneous branch the runs at the level of the ASIS, providing innervation to the skin and subcutaneous tissues of the inguinal region. For orchidopexy surgery, additional local anesthetic may be needed if the scrotal incision is towards the apex of the scrotum (posterior - perineal nerve vs anterolateral - genito-femoral nerve) rather than on the anterior aspect.

Study Goals and Objectives Primary Objective - To introduce a new technique of IHN/IIN blocks that is equianalgesic to the single-shot technique without requiring ultrasound guidance.

Secondary Objective - To introduce a technique that has a lower incidence of unintended femoral nerve block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I-II children aged 0-16 presenting for inguinal surgery (inguinal hernia, hydrocele repair, or orchidopexy)

排除标准

  • Patient or parent refusal to participate in study, local anesthetic allergy, or any other contraindication to ilio-inguinal nerve block.

结局指标

主要结局

Time to completion of block for equal analgesia (intraoperative or post-operative need for rescue analgesia)

时间窗: From identification of needle insertion site to end of injection of local anesthetic (single shot blocks are typically completed within 5 minutes)

Time (in seconds/minutes) taken to achieve a satisfactory ilioinguinal nerve block will be recorded.

次要结局

  • Time to onset of block(When maximal nerve block is achieved (after approximately 20 minutes for single-shot blocks))
  • Change in heart rate upon surgical incision(At the moment the skin incision is made (varies; intra-operative))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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