Comparative Analysis of Incidence of Newly Developed Postoperative Low Back Pain with Field Block Versus Without Field-block Before Spinal Anaesthesia for Patients Undergoing Caesarean Sections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Incidence of postoperative back pain
研究概览
简要总结
The study aimed to evaluate the effectiveness of field block in preventing postoperative low back pain (PDPB) in patients undergoing Cesarean Sections.
详细描述
The purpose of this study was to evaluate the effectiveness of field block with lidocaine 2% (5 ml) administered with a 24G hypodermic needle before spinal anesthesia for patients undergoing LSCS, in preventing the development of postoperative low back pain (PDPB). The study aimed to determine if using a field block would decrease the incidence of PDPB compared to patients who received only spinal anesthesia.
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
- Single (Outcomes Assessor)
盲法说明
The person assessing the pain scores and the other observation parameters in the postoperative period was blinded to the group to which the patient was assigned.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing LSCS under spinal anesthesia, ASA Grade 2 and Grade 2E and willing to participate in the trial
排除标准
- •Spine pathology/instability and coagulopathy, ASA Grade 3 and above, Pre-exiting low back pain, Morbid Obesity (BMI > 35), Patients needing more than 1 attempt for administration of spinal anaesthesia, Patients utilizing labour analgesia, Local infection or inflammation at the site of spinal anesthesia/field block, Unwilling to participate
结局指标
主要结局
Incidence of postoperative back pain
时间窗: 90 days
Post operative back pain was assessed using a questionnaire specifically designed to evaluate back pain and transient neurological symptoms (e.g., unilateral or bilateral pain or radicular pain in the buttock, thigh, calves, or legs). Twenty-four hours after surgery, the patients were assessed for incidence and level of low back pain. In patients with back pain, the characteristics, aggravating factors, and degree of back pain was assessed using a numeric NRS. The same questionnaire was used telephonically to assess pain at 7 days, 1 month and 3 months after surgery.
次要结局
- Birth weight of the child(1 day)
- Period of gestation (weeks)(Weeks between conception and birth when a baby through Caesarean Section)
- Gravida(1 day)
研究者
Dr.Deb Sanjay Nag
HOD & Head Consultant Anaesthesiology
Tata Main Hospital