Comparison of the Efficacy of Sacral Erector Spinae Plane Block (SESPB) and Pudendal Block on Postoperative Pain and Catheter-related Bladder Discomfort (CRBD) in Patients Undergoing Trans-urethral Resection of the Prostate (TUR-P).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort
研究概览
简要总结
The goal of this clinical trial is to evaluate the catheter related bladder discomfort in patients who will undergoing TUR-P operation. The main questions it aims to answer are:
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Is sacral ESPB effective on the pudendal nerve dermatome?
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Is sacral ESPB as useful as pudendal block on CRBD? Participants will be divided into two groups and the first group will receive sacral espb after TUR-p operation and the second group will receive pudendal block. Investigators will be present for 24 hours
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catheter related bladder discomfort
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post-operative pain,
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additional analgesic needs will be questioned and the difference between the two groups will be evaluated.
详细描述
This is a prospective,randomised,double-blind, single-centre,study aiming to compare the effectiveness of US guided bilateral sacral ESPB and US guided bilateral pudendal block on CRBD and pain after TUR-P. 54 patients will be included in the study and divided into two groups. All patients will be standardly monitored and will receive general anaesthesia. At the end of the cases, sacral ESPB will be applied to the first group and pudendal block to the second group, and the patients and the data questioner physician will be blinded to the study.
Primary and secondary outcomes will be questioned for 24 hours and statistics will be made according to the result.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist (ASA) Physical status 1-3
排除标准
- •American Society of Anesthesiologist (ASA) Physical status 4-5
- •Refused to participate in the study
- •Known allergy to local anaesthetic
- •Where regional anaesthesia is contraindicated
- •With known neurological, haematological or muscular disease
- •Patients with infection or anatomical changes in the lumbo-sacral region
结局指标
主要结局
Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort
时间窗: baseline ,and 24 hours
It was evaluated with a 4-point scoring system developed and first used by Agarwall et al. . No symptoms: 0, Mild: mild discomfort that can be tolerated, Moderate: discomfort is present but not accompanied by behavioural reactions, Severe: discomfort is very severe and accompanied by body movements indicating that the patient cannot bear it.
次要结局
- Numerical Rating Scale,0 :no pain 10:worst pain(baseline, and 24 hours)
研究者
Bilge Olgun Keles
Assistant professor
Giresun University