Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Post-defecatory pain score during the first 10 postoperative days
研究概览
简要总结
The goal of this clinical trial is to learn if a topical ointment containing two local anesthetics (lidocaine 23% and tetracaine 7%) can reduce pain after hemorrhoid surgery in adults. The main questions it aims to answer are:
- Does the ointment lower post-defecation pain movements in the first 10 days after surgery?
- Does the ointment lower overall daily pain in the 10 days after surgery?
- Does the ointment reduce the need for rescue pain medication (tramadol)?
Researchers will compare the lidocaine/tetracaine ointment to a placebo (a look-alike ointment that contains no active drug) to see if the active ointment works better to reduce pain after hemorrhoid surgery.
Participants will:
- Apply the ointment or placebo to the anal area every 12 hours for 10 days after surgery
- Rate their pain on a scale from 0 to 10 each day, including pain after bowel movements/defecation
- Record how many times they take rescue pain medication each day
- Receive check-in calls/mesages from the research team after surgery
详细描述
Background
Hemorrhoidectomy is the most effective surgical treatment for advanced hemorrhoidal disease, but it is associated with significant postoperative pain, particularly during bowel movements. Standard multimodal analgesia regimens, including scheduled non-steroidal anti-inflammatory drugs, acetaminophen, and opioid rescue doses, often provide incomplete relief, especially during defecation. Topical local anesthetics have been explored as adjuvant analgesic agents in this setting, but commercially available formulations use low concentrations (typically 2-2.5%) that may limit their efficacy. High-concentration compounded formulations containing lidocaine 23% and tetracaine 7% have demonstrated an adequate pharmacokinetic safety profile in other clinical settings, but had not been evaluated in proctological surgery prior to this trial.
Study Design
This was a single-center, double-blind, placebo-controlled randomized controlled trial (RCT) conducted at a private academic institution in Santiago, Chile. Participants were randomized in a 1:1 ratio to receive either active ointment (lidocaine 23%/tetracaine 7%) or an identical-appearing placebo ointment. Randomization was performed using a computer-generated sequence with allocation concealment via an encrypted randomization. Both participants and the surgical team were blinded to treatment allocation throughout the follow-up period. The ointments were prepared and labeled by an independent compounding pharmacy, and were identical in color, texture, and packaging.
Intervention
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, Care Provider, Investigator)
盲法说明
Statistical analysis was performed while the investigative team remained blinded to group allocation, with groups identified only as "Group A" and "Group B". Treatment allocation was revealed only after the analysis was complete and the results had been interpreted.
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
- •Age 18 years or older
- •Scheduled for elective hemorrhoidectomy
- •Recruited consecutively on the day of surgery
- •Able to provide written informed consent
排除标准
- •Inflammatory bowel disease
- •Immunosuppression
- •Pregnancy
- •Chronic pain requiring ongoing analgesic treatment
- •Known hypersensitivity to any of the study medications
- •Significant cardiovascular disease
- •Peripheral vascular disease
- •Cerebrovascular disease
- •Hepatic disease
- •Seizure disorders
结局指标
主要结局
Post-defecatory pain score during the first 10 postoperative days
时间窗: Postoperative days 1 through 10
Self-reported post-defecatory pain intensity assessed using a 0-10 visual analogue scale (VAS), recorded by participants immediately after each bowel movement. The primary outcome is the mean of available daily post-defecatory VAS scores across postoperative days 1 through 10. On days with more than one bowel movement, the daily score represents the mean of all recordings. Days without a bowel movement are excluded from the calculation.
次要结局
- Mean daily pain score(Postoperative days 1 through 10)
- Cumulative rescue opioid consumption(Postoperative days 1 through 10)
- Adverse effects related to the study ointment(Postoperative days 0 through 10)
- Postoperative complications within 30 days(30 days postoperatively)
- Mean post-defecatory pain score during postoperative days 1-5(Postoperative days 1 through 5)
- Mean daily pain score during postoperative days 1-5(Postoperative days 1 through 5)
研究者
Felipe Bellolio Roth
Dr.
Pontificia Universidad Catolica de Chile