Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 4
- 主要终点
- incidence of bilateral sacral blockade
研究概览
简要总结
This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I and II
- •Height(150-170 cm)
排除标准
- •patient refusal
- •hypersensitivity to local anesthetic drugs
- •bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
结局指标
主要结局
incidence of bilateral sacral blockade
时间窗: Up to 30 minutes after local anesthetic injection
Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)
次要结局
- Onset of sensory blockade(Up to 30 minutes after local anesthetic injection)
- Maximum achieved sensory level(Up to 30 minutes after local anesthetic injection)
- Time to achieve the maximum sensory level(Up to 30 minutes after local anesthetic injection)
- Onset of motor blockade(Up to 30 minutes after local anesthetic injection)
- Time to complete motor block(Up to 30 minutes after local anesthetic injection)
- Duration of motor block(Assessed every 20 minutes after achieving Bromage 3 motor block)
- Duration of analgesia(Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively)
- Duration of sensory block(Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia)
- Number of epidural top-ups(Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery)
- Sedation score(Assessed every 20 minutes during the surgical procedure and postoperatively)
- Hemodynamic parameters(Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms)
- Perioperative side effects(During surgical period up to 7 days post-operatively)
研究者
Reham Ali Abdelhaleem Abdelrahman
Lecturer of Anesthesia
Cairo University