Laparoscopic Transversus Abdominis Plane Block (LTAP) (Tap Block) for Appendicectomy Versus Standard Port Site Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 主要终点
- Assessing pain post laparoscopic appendicectomy using Visual analogue score (VAS score)
研究概览
简要总结
This study aims to compare Laparoscopic assisted LTAP (Transversus Abdominis Plane) to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3, 6, 12 and 24 hours following laparoscopic appendicectomy Tap Block is a standard conventional analgesia protocol for laparoscopic appendicitis used in Beaumont Hospital, and other hospitals throughout Ireland.
The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block
详细描述
Title: Randomised Controlled Trial to compare Laparoscopic Transversus Abdominis Plane Block (LTAP) for appendicectomy versus standard treatment Short title: (TAP Block Study) Laparoscopic Transversus Abdominis Plane Block for Appendicectomy - Single-Blinded Randomised controlled study
Objectives: Primary objectives:
To compare LTAP to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3,6, 12 and 24 hours following laparoscopic appendicectomy
Secondary objectives:
Post-operative Opioid requirement Time to first mobilisation post-operatively Length of stay in hospital Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)
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, Outcomes Assessor)
盲法说明
Single blinded randomised control trial
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
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for follow up telephone follow up
- •Male or female, aged over 18
- •Diagnosed either clinically or radiologically (CT/US/MRI) with appendicitis
- •Uncomplicated or complicated appendicitis
- •Undergoing laparoscopic appendicitis surgery only
- •Must be fluent in English in order to complete telephone follow up questionnaire
- •Fulfillment of each criteria must be clearly evidenced (in lab reports or correspondence) and/or documented in the medical records.
排除标准
- •Male or female under the age or 18
- •Laparoscopic converted to open appendicectomy (during surgical procedure)
- •Open appendicectomy (planned)
- •Pregnancy.
- •Females must not be breastfeeding
- •Known allergic reactions to components of the study product(s) )
- •Not fluent in English - which would prevent participants to complete follow up telephone questionnaire
- •Malignant appendicitis
- •Spinal Anaesthesia, Epidural analgesia catheter or injections, Post-operative requirements for patient controlled analgesia (PCA)
- •Right hemicolectomy or any concomitant or simultaneous intervention
- •Allergy or hypersensitivity to any of the components of Bupivacaine
- •Presence of any other illness or condition that renders the patient unsuitable for trial participation in the opinion of the investigator
结局指标
主要结局
Assessing pain post laparoscopic appendicectomy using Visual analogue score (VAS score)
时间窗: Assessing change in pain score post extubation at 3 hours, 6 hours, 12 hours and 24 hours.
Assessing any change in pain score from a scale of 1 to 10 (1 being the worst pain and 10 no pain) using VAS score template
次要结局
- Post-operative Opioid requirement(Assess opioid requirement post operatively in the first 24 hours)
- Length of stay in hospital(Assess length of stay from admission to discharge)
- Time to first mobilisation post-operatively(Assess time to mobility in the first 24 hours post operatively)
- Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)(1 week (up to 7 days) and 1 month up to 30 days post discharge from hospital)