Efficacy of Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) as a Sole Anesthetic for Open Inguinal Hernia Repair Versus Spinal Anesthesia: A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- NRS 4 hours postoperative
研究概览
简要总结
The aim of this study is to evaluate success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia by comparing intraoperative and postoperative complications, pain control and patient and surgeon satisfaction of the block with spinal anesthesia.
详细描述
Open Inguinal hernia repair is one of the commonest procedures performed worldwide. Still, there is no consensus regarding the optimum anesthesia technique for this surgery. General, spinal, epidural and local anesthesia techniques have all been used, each having its own advantages and disadvantages.
General anesthesia carries risks of possible airway complications, postoperative deterioration of cognitive function, sore throat, nausea, vomiting and prolonged period of immobilization with associated risk of deep vein thrombosis and longer hospital stay. Spinal anesthesia, although effective, is not without risk in patients with decompensated heart disease, recent head injury, convulsions and coagulopathies. Also spinal and epidural anesthesia have been associated with hemodynamic instability, vomiting, urinary retention, post-dural puncture headache, and backache.
Use of pre-incision infiltration of local anesthetics for field blocks has been found to be an effective adjunct as well as an alternative to spinal and general anesthesia in many studies. Combined with sedation or on its own, it offers less cardiovascular instability, early ambulation and effective post-operative pain control. Also, it has been found to reduce hospital costs by 50% and gives better patient satisfaction.
Harvey Cushing and William Halsted first described the inguinal field block in 1900. since then, its efficacy and advantages have been compared by many surgeons and anesthesiologists in a number of studies. Refinements and modifications in the technique still continue. In 1963, Joseph L Ponka described in great detail a seven step procedure of performing it in 837 patients successfully.
In 1994, Parvis and colleagues did a step by step technique for local anesthetic infiltration field block for open inguinal hernia repair.
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
Single blinded
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
- 否
入选标准
- •ASA score I, II or Ш.
- •Patients with unilateral inguinal hernia for elective open mesh repair hernioplasty operation.
排除标准
- •Bilateral, recurrent or complicated inguinal hernia.
- •Emergency operations or operation that lasts more than two hours.
- •Patients with drug or alcohol abuse history.
- •Chronic pain, with daily use of analgesics.
- •Contraindication to local anesthesia.
- •Contraindication of spinal anesthesia.
研究组 & 干预措施
Group A
US guided five step field block will be performed
干预措施: US guided five step field block (Procedure)
Group B
Spinal anesthesia will be administered in sitting position
干预措施: Spinal anesthesia (Procedure)
结局指标
主要结局
NRS 4 hours postoperative
时间窗: 4 hours
Numerical Rating pain score 4 hours postoperative
次要结局
- Intra operative patient satisfaction(12 hours)
- Intra operative surgeon satisfaction(12 hours)
- Time for ambulation(12 hours)
- Time of first rescue analgesic dose(12 hours)
- Incidence of Side effects(12 hours)
- NRS 30 minutes postoperative(30 minutes)
- NRS 12 hours postoperative(12 hours)
- Total analgesic dose in the first 12 hours postoperative(12 hours)
研究者
Eslam Ayman Mohamed Shawki
Lecturer of anesthesia, SICU & Pain Management
Cairo University