Effects of Ultrasound-guided Pudendal Nerve Block on Postoperative Pain and Quality of Recovery in Patients Undergoing Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain score on the numeric rating scale (NRS) at 12 hours
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.
详细描述
Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids)
- •Age 20 to 65 years old
- •American Society of Anesthesiologists (ASA) classification I~III
- •Receiving Ferguson hemorrhoidectomy under spinal anesthesia
排除标准
- •Allergy to local anesthetics or analgesics used in this study
- •Drug abuse
- •Coagulopathy
- •An active infection at the injection site
- •Patient refusal
- •Pregnancy
研究组 & 干预措施
Pudendal block group
Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side)
干预措施: Pudendal nerve block (Procedure)
Placebo group
Receiving bilateral pudendal nerve block with normal saline (10 ml each side)
干预措施: Placebo block (Procedure)
结局指标
主要结局
Postoperative pain score on the numeric rating scale (NRS) at 12 hours
时间窗: 12 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 48 hours
时间窗: 48 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Quality of recovery at baseline
时间窗: Baseline
Quality of recovery-15 questionnaire measures the baseline quality of recovery
Opioid consumption at 12 hours
时间窗: 12 hours after hemorrhoidectomy
Morphine equivalent dose
Opioid consumption at 7 days
时间窗: 7 days after hemorrhoidectomy
Morphine equivalent dose
Quality of recovery at 48 hours
时间窗: 48 hours after hemorrhoidectomy
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Pain score on the numeric rating scale (NRS) at baseline
时间窗: Baseline
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 24 hours
时间窗: 24 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 6 hours
时间窗: 6 hours after hemorrhoidectomy
Morphine equivalent dose
Postoperative pain score on the numeric rating scale (NRS) at 6 hours
时间窗: 6 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 24 hours
时间窗: 24 hours after hemorrhoidectomy
Morphine equivalent dose
Quality of recovery at 7 days
时间窗: 7 days after hemorrhoidectomy
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Postoperative pain score on the numeric rating scale (NRS) at 7 days
时间窗: 7 days after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 48 hours
时间窗: 48 hours after hemorrhoidectomy
Morphine equivalent dose
Quality of recovery at 24 hours
时间窗: 24 hours after hemorrhoidectomy
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
次要结局
- Patient satisfaction with pain control(24 hours after hemorrhoidectomy)
- Time to the first urination(Up to 48 hours after hemorrhoidectomy)
- Time to the first defecation(Up to 48 hours after hemorrhoidectomy)
- Postoperative complications(Up to 7 days after hemorrhoidectomy)
- Time to first rescue analgesics(Up to 7 days after hemorrhoidectomy)