Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- mean level of pain, as assessed by visual analog scale (VAS)
研究概览
简要总结
Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal surgery.
详细描述
120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre.
Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-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
- Triple (Participant, Investigator, 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 undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids
- •Use of subarachnoid anesthesia with lidocaine
排除标准
- •Allergy or Hypersensitivity to lidocaine or other local anesthesics.
- •Patients not accepting subarachnoid anesthesia
- •Patients with general anesthesia
- •Hypersensitivity or contraindication to acetylsalicylic acid.
- •History of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (NSAIDs) use
- •Active or relapsing peptic ulcer/gastrointestinal hemorrhage
- •Serious heart failure.
- •Active Crohn disease
- •Active ulcerative colitis
- •Moderate or sever renal failure
- •Severe liver disfunction
- •Coagulation disorders requiring treatment with anticoagulant drugs
- •Proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases
- •Treatment with: Beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids
- •Pregnancy
研究组 & 干预措施
Clife2 gel (lidocaine)
Clife2 gel (lidocaine) Topical gel containing lidocaine (2%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6
干预措施: local anesthesics, CLIFE2 (Drug)
Clife1 gel (lidocaine plus diclofenac)
Clife1 gel (lidocaine plus diclofenac) Topical gel containing lidocaine (2%) plus diclofenac (0.5%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6
干预措施: anesthesics plus antiinflammatory, CLIFE1 (Drug)
结局指标
主要结局
mean level of pain, as assessed by visual analog scale (VAS)
时间窗: 3 days post-surgery
次要结局
- analgesics use(6 days post-surgery)
- Pain relief(6 days post-surgery)
- demographic and clinical characteristics-1(baseline)
- Mean level of pain (VAS) at day 3 post-surgery(6 days post-surgery)
- Level of pain (VAS), assessed by Andersen scale(6 days post-surgery)
- patient satisfaction(6 days post-surgery)
- demographic and clinical characteristics-2(baseline)
- safety evaluation as assessed by recording fo adverse events(6 days post-surgery)
研究者
María José Linares Gil
Doctor
Hospital de Viladecans