Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery: Study Protocol for Prospective, Randomized, Placebo-controlled, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- rate of prescribing opioid analgesics
研究概览
简要总结
Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction.
Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. All participants are randomly divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second one gets a tablet containing starch per os 14 days before surgery (72 participants per arm). Then patients of each group will continue MFF administration for 30 days after surgery. Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the severity of the postoperative pain syndrome, duration and frequency of other drugs intake, readmission rate, overall quality of life, time from the procedure to returning to work and the complications rate, C-reactive protein level.
Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms during conservative treatment. In addition, the Detralex® efficacy has been proven in postoperative pain reduction for patients diagnosed with varicose veins of the lower extremities. The investigators intend to evaluate the feasibility of the preoperative MFF administration for the postoperative pain reduction and the decrease of the postoperative complications in patients with hemorrhoidal disease.
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)
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
- •Stage 2-4 hemorrhoidal disease;
- •Presence of indications for elective surgery (open hemorrhoidectomy) using mono or bipolar coagulation possibly combined with other minimally invasive methods: hemorrhoidopexy and mucopexy, Ligasure hemorrhoidectomy;
- •Absence of other diseases that cause pain;
- •Class I, II ASA anesthesia risk;
排除标准
- •The presence of the following diseases: paraproctitis, inflammatory bowel disease, metabolic or endocrine disorders, alcoholism, drug use, blood clotting disorders, and history of diseases in the anorectal region;
- •Contraindicated or technically impossible subarachnoid anesthesia;
- •Patients who refused to participate;
- •Pregnant women.
研究组 & 干预措施
Experimental group
Patients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery
干预措施: micronized flavonoid fraction (Drug)
结局指标
主要结局
rate of prescribing opioid analgesics
时间窗: 7 days after surgery
the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery
次要结局
- readmission rate(30 days after surgery)
- other medications use(7 days after surgery)
- complication rates(within 30 days after the procedure)
- pain at rest and during defecation(15 days after surgery)
- The life quality rate(7 and 30 days)
- time from surgery to return to work(during 30 days after surgery)