A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Amount of analgesic use
研究概览
简要总结
Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.
详细描述
Study Design: This will be a patient-and-investigator blinded factorial randomised trial with four parallel groups. Participants in all four groups will be instructed to apply cream 3 times a day for 7 days after surgery. A standard analgesia prescription will be provided with laxatives as per routine care. Patients will be provided a questionnaire to complete and return on day 14.
Random Sequence Generation: Computer generated sequence allocating patients to a 1:1:1:1 ratio using permuted block randomisation in blocks of 12.
Allocation Concealment: This randomisation code will be seeded to the pharmacist to who will package and label the cream according to a code. The creams will be indistinguishable to which active ingredient they contain.
Assignment of intervention: Patients will be assigned in order according to the numbering of the cream tubes by the blinded investigator.
Data recording: Data will be recorded on Redcap database.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double blinded trial, both participant and investigator are blinded.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing excisional haemorrhoidectomy
排除标准
- •Age <16,
- •history of chronic pain,
- •drug allergy or idiosyncracies to any actives or excipients in
- •breastfeeding,
- •any medical history which is a contraindication to any of metronidazole, lidocaine, or diltiazem including including:
- •sick sinus syndrome,
- •atrioventricular block,
- •hypotension,
- •heart failure and bradycardia.
- •concomitant medications which are contraindicated to metronidazole, lidocaine or diltiazem.
- •patients already taking diltiazem.
研究组 & 干预措施
Metronidazole
Group A receiving 10% metronidazole cream
干预措施: Metronidazole cream (Drug)
Metronidazole + Diltiazem
Metronidazole 10% + Diltiazem 2%
干预措施: Metronidazole and Diltiazem cream (Drug)
Metronidazole + Lignocaine
Metronidazole 10% + Lignocaine 4%
干预措施: Metronidazole and Lidocaine cream (Drug)
Metronidazole + Diltiazem + Lignocaine
Metronidazole 10% + Diltiazem 2% + Lignocaine 4%
干预措施: Metronidazole, Diltiazem and Lidocaine cream (Drug)
结局指标
主要结局
Amount of analgesic use
时间窗: 7 days
Morphine equivalent amount
Pain scores
时间窗: 7 days
Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain
次要结局
- Pain on bowel motion: Visual Analog Scale(7 days)
- Complications(30 days)
- Re-admission(30 days)
- Return to work(14 days)
- Repeat Prescription(30 days)
研究者
Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS
Professor of Surgery, Head of School
University of Auckland, New Zealand