Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Appendicectomy in Adults: A Double Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Opioid consumption in the first 12 hours after the operation
研究概览
简要总结
Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence of nausea, vomiting and sedation which can complicate post-operative recovery. Different techniques of intraoperative infiltration of local anaesthetic to control postoperative pain are also being used. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects.
Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital discharge.
The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in the investigator's hospital.
详细描述
Summary of Study Design: The study will be a double blind randomised controlled trial with patients undergoing laparoscopic appendicectomy randomly allocated into two groups. The study group will receive bilateral TAP blocks and the control group will receive local anaesthetic infiltration of the laparoscopic port sites
A double blind design was chosen to eliminate patient and observer bias in reporting of pain scores.
The presence of the control arm will ensure that any difference observed will be due to the effect of sensory nerve block due to the TAP block than due to the systemic effect of the injected local anaesthetic.
The null hypothesis will be that there is no difference between the groups in the amount of opioids consumed by the patients during 24 hours after the operation. The investigators chose this measurement as an objective but indirect measurement of efficacy of TAP block and pain relief thus received. Measurement of pain with various scoring methods are reliable only when concurrent reduction in consumption of pain killers are demonstrated.
Recruitment and randomisation:
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)
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
- 否
入选标准
- •Participants willing and able to give informed consent for participation in the study
- •Male or Female, aged 16 years or above
- •Undergoing laparoscopic appendicectomy for a clinical diagnosis of appendicitis
- •American Society of Anaesthetists physical status (ASA) 1-3
排除标准
- •Opioid tolerance
- •Chronic abdominal pain
- •Allergy/Intolerance: Morphine, local anaesthetics, tramadol
- •BMI (Body Mass Index) >35 Kg/M2
- •Previous major abdominal surgery
- •High likelihood of conversion of open procedure
- •Patients unable to communicate in written and spoken English
- •Weight less than 50 kg
结局指标
主要结局
Opioid consumption in the first 12 hours after the operation
时间窗: 12 hours
The primary endpoint will be consumption of morphine or other opioids (including tramadol) in the first 12 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios.
次要结局
- Total length of hospital stay(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected length of 1-5 days)
- Time to first request for rescue analgesia(24 hours after the operation)
- Numerical rating pain scores at emergence, 6, 12, 24 hours postoperatively(24 hours after the operation)
- Nausea score at emergence, 6, 12, 24 hours postoperatively(24 hours after the operation)
- Opioid consumption at 24 hours(24 hours after the operation)