Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The recovery time
研究概览
简要总结
Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.
Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients
详细描述
- Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
- Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the patient.
- •Age: 21-60 years old.
- •Sex: both sex (males and females).
- •American Society of Anesthesiologist Physical status: ASA 1& II.
- •Body Mass Index (BMI) = (25-30 kg/m2).
- •Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.
排除标准
- •Altered mental state.
- •Patients with known history of allergy to study drugs.
- •Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- •Patients with chronic pain.
- •Patients receiving anticoagulants.
- •Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
结局指标
主要结局
The recovery time
时间窗: up to 1 hour postoperative
The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors.
次要结局
- pain intensity(up to 24 hours postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
principle investigator
Zagazig University