Impact of Ultrasound-Guided Spinal Anesthesia and Pre-Procedure Sedation on Postoperative Acute and Chronic Back Pain in Non-Obstetric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Back Pain
研究概览
简要总结
This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. By comparing standard techniques, ultrasound guidance, and sedation, we aim to find safer and more comfortable approaches for patients undergoing non-obstetric surgery.
详细描述
Spinal anesthesia is widely used for abdominal and lower limb surgeries, yet a significant number of patients experience new back pain afterward, sometimes lasting for months. Contributing factors include needle size, multiple puncture attempts, and patient characteristics. Ultrasound guidance can improve accuracy and reduce complications, while pre-procedure sedation may lower anxiety and discomfort during the procedure.
This randomized controlled trial will include 180 adult patients scheduled for non-obstetric surgery. Participants will be divided into three groups:
Ultrasound-guided spinal anesthesia without sedation
Ultrasound-guided spinal anesthesia with sedation (midazolam)
Landmark-guided spinal anesthesia (control)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation)
干预措施: Ultrasound-guided spinal anesthesia (Procedure)
Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)
干预措施: Midazolam plus ultrasound-guided spinal anesthesia (Drug)
Arm C - Landmark-Guided Spinal Anesthesia (Control)
干预措施: Landmark-guided spinal anesthesia (Procedure)
结局指标
主要结局
Incidence of Postoperative Back Pain
时间窗: 24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery
Presence of pain or discomfort at the lower back or puncture site, assessed using a pain body map and Numeric Rating Scale (0-10). Evaluations will be performed both in the early postoperative period and during follow-up.
次要结局
- Severity of Postoperative Back Pain(24-48 hours; 1 month, 3 months, and 6 months postoperatively)
- Number of Needle Insertion Attempts(During the procedure)
- Patient Satisfaction(24 hours postoperatively)
- Procedure-Related Complications(Within 7 days postoperatively)
研究者
Samar Rafik Mohamed Amin
Assistant professor of anesthesia and intensive care
Benha University