The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Julie Dawson
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Patient recruitment rate
研究概览
简要总结
The investigators' aim is to assess if they can complete a study measuring the effect of local anaesthetic gel (Instillagel) on reducing pain experienced by patients undergoing a common treatment for haemorrhoids (piles). This treatment is called rubber band ligation and is commonly performed in the investigators'clinics.
详细描述
A feasibility trial assessing patient recruitment, retention, randomization, and surgeon acceptability of topical anaesthetic use during rubber band ligation of haemorrhoids.
A patient and assessor blinded feasibility trial. The trial population will prospectively be recruited from colorectal surgery outpatients. Patients will be randomized to two groups to receive: lubricating gel (K-Y Jelly) and topical anaesthetic gel (Instillagel) or lubricating gel alone (the standard care).
The intervention group will receive lubricating gel and topical anaesthetic gel (containing lidocaine active ingredient) administered rectally, whilst the control group will receive lubricating gel alone (standard care). This will be carried out in Colorectal Outpatients. The band ligation of the haemorrhoids should occur between 5-10 minutes after administration of the topical anaesthetic/lubricating gel. Pain scores and the use of oral analgesia will be measured immediately after the procedure (5 minutes), upon leaving the clinic (approximately 30 minutes after), at 4 hours, and 72 hours following the procedure. Vasovagal symptoms or other complications will be recorded whilst the patient is in the clinic. At 1 month post procedure, patients will be phoned to determine if any adverse events have occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinded to assessors and patients
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language.
排除标准
- •Allergy to active ingredients of Instillagel, Allergy to local anaesthetic, Chronic liver disease, Grade 4 haemorrhoid disease, Pregnancy, Inflammatory bowel disease, Pre-existing anorectal disease.
研究组 & 干预措施
Intervention Arm
topical anaesthetic gel and lubricating gel
干预措施: Instillagel (Drug)
Intervention Arm
topical anaesthetic gel and lubricating gel
干预措施: KY Gel (Other)
Control Arm
lubricating gel alone
干预措施: KY Gel (Other)
结局指标
主要结局
Patient recruitment rate
时间窗: 5 months
Patient recruitment rate via screening log.
Treatment acceptability to patients
时间窗: 5 months
Treatment acceptability to patients via study questionnaire. A visual analogue scale to be used, 0 - 10 with '0' being no pain and '10' being worst pain possible.
Patient retention
时间窗: 5 months
Patient retention via recruitment log.
次要结局
- Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure(72 hours)
- Assess if the intervention reduced oral analgesia burden following the procedure(72 hours)
- Assess hospital readmission 1 month after the procedure.(1 month)
- Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure,(72 hours)
研究者
Julie Dawson
Research Services Manager
Norfolk and Norwich University Hospitals NHS Foundation Trust