Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)
研究概览
简要总结
In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa:
Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound
The primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).
详细描述
This is a multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).
Study Duration The total study duration per patient is 7 days. The recruitment period is set at 12 months.
Justification of the Experimental Protocol The aim of this study is to compare two methods of performing a pudendal block. Patient allocation to either strategy will be determined by randomization. Bilateral pudendal nerve block and its branches in the ischioanal fossa will be performed after induction of general anesthesia.
To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.
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, Investigator)
盲法说明
To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.
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
- •Adult male or female patient
- •Patient who has signed informed consent to participate in the study
- •Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia
排除标准
- •History of hemorrhoidal surgery
- •Allergy or contraindication to any of the medications used in the study
- •Patient undergoing surgery under spinal anesthesia
- •History of chronic pain requiring opioid use, unrelated to hemorrhoids
- •Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol
- •Patient not affiliated with the French national health insurance system
- •Patient under legal protection (e.g., guardianship, trusteeship, or court protection)
- •Pregnant woman or woman at risk of being pregnant (i.e., of childbearing age without effective contraception and without an HCG test)
- •Patient already enrolled in another therapeutic clinical trial or within the exclusion period of another clinical trial
结局指标
主要结局
Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)
时间窗: Hour 2
The primary endpoint of the study is the maximum pain score in the Post-Anesthesia Care Unit (PACU) before morphine titration. Postoperative pain in the recovery room will be recorded by the nursing staff using a simple numeric scale from 0 to 10 after questioning the patient, following standard departmental procedures. The maximum pain score before morphine titration constitutes the primary evaluation criterion.
次要结局
- Quantitative Opioid Consumption(Hour 2)
- Qualitative Opioid Consumption(Hour 2)
- Postoperative recovery assessment(Day 7)
- Postoperative Pain assessment at rest(Day 7)
- Postoperative Pain assessment during walking(Day 7)
- Postoperative Pain assessment during First defecation(Day 7)
- Non-Opioid Postoperative Medication Use(Day 1)
- Pudendal block procedure duration(Hour 2)
- Sensory block duration(Day 7)
- Length of stay in the PACU(Day 1)
- Total hospital stay duration(Day 1)
- Time to first defecation(Day 7)
- Tolerance(Day 7)