Intraoperative Use of Perineal Block for Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The rate of opioid analgesics usage
研究概览
简要总结
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia The purpose of this study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.
详细描述
Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics.
Traditionally spinal or general anesthesia is used in proctological practice. However, the number of studies about using of perianal local anesthesia, both in combination with general anesthesia and as a separate practice has been increasing recently.
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia. The drugs used for this have some pharmacological differences in the duration of the drug and the form of administration.
The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.
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
Randomization of the patients included in the study was performed before surgery. Patients were being randomly divided into two groups. All patients getting subarachnoid anesthesia. Perineal block using solution of ropivocaine and epinephrine for the first group was performed and placebo with epinephrine - for the second group. A researcher who does not participate in the surgery and does not contact with patients at all perioperative stages performs randomization and prepares a solution block. Neither the patient nor the operating surgeon and the doctors who register the results of the treatment are not informed about the anesthesia used in each case.
The probability of introduction to each group is 50%. The number of patients in both groups equally and is 50 people.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Patients over 18 years.
- •Symptomatic grade III-IV hemorrhoids.
- •Planned surgery: Milligan-Morgan hemorrhoidectomy.
排除标准
- •Patient's refuse to participate in the study.
- •Сontraindications or technical inability to perform subarachnoid anesthesia.
- •Decompensated somatic diseases.
- •Inflammation of the perianal region.
研究组 & 干预措施
epinephrine + ropivacaine +saline
1% epinephrine solution + 30 ml of 1% ropivacaine solution diluted with 20 ml of 0.9% saline for achievement a 0.75% anesthetic solution in a ratio of 1: 200 000
干预措施: perineal block with usage of one of solutions (Procedure)
epinephrine + ropivacaine +saline
1% epinephrine solution + 30 ml of 1% ropivacaine solution diluted with 20 ml of 0.9% saline for achievement a 0.75% anesthetic solution in a ratio of 1: 200 000
干预措施: epinephrine + ropivacaine +saline (Drug)
epinephrine + saline
1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.
干预措施: perineal block with usage of one of solutions (Procedure)
epinephrine + saline
1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.
干预措施: epinephrine + saline (Drug)
结局指标
主要结局
The rate of opioid analgesics usage
时间窗: 1 day - 2 weeks
The need to use opioid analgesics.
次要结局
- systemic analgesics usage(1 day - 2 weeks)
- re-admission(1 day - 1 month)
- The duration of painless period after surgery(1 day - 1 week)
- quality of life with SF-36 questionnaire(1 day - 1 month)
- The timing of returning to work.(1 day - 1 month)
- early postoperative complications(1 day - 1 month)