Pudendal Nerve Block in Patient Treated for Hemorrhoidectomy Under Spinal Anaesthesia: Prospective Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Postoperative Pain on the Visual Analogue Scale (VAS)
研究概览
简要总结
Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.
详细描述
Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age < 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by haemorrhoids (grade III and IV) and treated with Milligan-Morgan hemorrhoidectomy under spinal anaesthesia
- •Signed informed consent
排除标准
- •Age < 18 years old
- •Pregnancy
- •Allergy to local anaesthetics
研究组 & 干预措施
Receiving the pudendal nerve block
干预措施: Local anesthetic (ropivacaine) (Procedure)
Not receiving the pudendal nerve block
干预措施: Local anesthetic (ropivacaine) (Procedure)
结局指标
主要结局
Postoperative Pain on the Visual Analogue Scale (VAS)
时间窗: at 24 hours after the hemorrhoidectomy
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
次要结局
- Postoperative Pain on the Visual Analogue Scale (VAS)(at 6, 12 and 48 hours after the operation)
- Opioids Consumption(Within 48 hours)
- Lenght of Hospital Stay(up to 2 weeks)
- Complications Related to the Pudendal Nerve Block(Within 6 weeks)
- Direct and Indirect Cost Analysis in Out- and In-patients(Within the hospital stay)
研究者
Francesco Mongelli
MD
Ospedale Regionale Bellinzona e Valli