A Double-Blind Randomized Controlled Trial of Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain management
研究概览
简要总结
Postoperative pain management remains a critical area of concern in surgical practices, especially in procedures involving the lower abdomen and pelvis. Inguinal Hernia is considered among few surgeries that may lead to chronic pain. Spinal anesthesia is a commonly utilized modality because of its efficacy in pain control and rapid recovery. However, the addition of peripheral nerve blocks, such as the ilioinguinal nerve block, may provide enhanced pain relief and reduce opioid consumption postoperatively. This study aims to evaluate the effectiveness of spinal anesthesia alone compared to spinal anesthesia supplemented with ultrasound-guided ilioinguinal and iliohypo-gastric nerve block in managing postoperative pain.
详细描述
Objectives
- Primary Objective: To compare the postoperative pain scores (using a standardized numerical rating scale) between patients receiving spinal anesthesia alone and those receiving spinal anesthesia with ultrasound-guided ilioinguinal nerve block.
- Secondary Objectives:
- To assess the total opioid consumption in the first 24 hours post-surgery.
- To evaluate the time to first analgesic request postoperatively.
- Patient Satisfaction score post-op >> at rest , coughing , ambulation ( LEKENT SCORE ) .
Hypotheses
- Hypothesis 1: Patients receiving spinal anesthesia with an ilioinguinal nerve block will experience significantly lower postoperative pain scores compared to those receiving spinal anesthesia alone.
- Hypothesis 2: Patients receiving spinal anesthesia with an ilioinguinal nerve block will require less opioid medication in the first 24 hours post-surgery.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-65 years
- •ASA physical status I-III
- •Scheduled for elective lower abdominal surgery (e.g., inguinal hernia repair, cesarean section)
排除标准
- •Allergy to local anesthetics
- •Coagulation disorders
- •Infection at the injection site
- •Patients with neurological conditions affecting lower limbs
研究组 & 干预措施
Intrathecal Mixture Block
15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc
干预措施: Ilioinguinal/iliohypogastric Nerve Block (Drug)
Intrathecal Placebo
17 cc of Ns/s
干预措施: Ilioinguinal/iliohypogastric with Placebo Block (Other)
结局指标
主要结局
Postoperative pain management
时间窗: 24 hours
Pain scores will be assessed using an 11-point numerical rating scale (0-10) at 1, 6, 12, and 24 hours postoperatively.
次要结局
未报告次要终点
研究者
Mohamad-Ali Barada
Anesthesia Attending
Makassed General Hospital