Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection- a Double Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Morphine Consumption in the First 48hours After the Operation
研究概览
简要总结
Laparoscopic (key-hole) large bowel resection 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. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery.
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, earlier return of bowel function 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 our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)
详细描述
Summary of Study Design The study will be a double blind randomised controlled trial with patients undergoing laparoscopic right hemicolectomy or laparoscopic high anterior resection randomly allocated into two groups, with the study group receiving bilateral TAP blocks followed by a morphine PCA and the control group receiving local anaesthetic infiltration of the laparoscopic port sites and specimen extraction site and a morphine PCA.
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 morphine consumed by the patients during 48 hours after the operation. We 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Undergoing elective laparoscopic high anterior resection without stoma or laparoscopic right hemicolectomy.
- •American Society of Anaesthetists physical status (ASA) 1-3
排除标准
- •Opioid tolerance
- •Chronic abdominal pain
- •Allergy/Intolerance: Morphine, local anaesthetics
- •BMI>35 Kg/M2
- •Previous major abdominal surgery
- •High likelihood of conversion to open procedure
- •Patients unable to communicate in written and spoken English
- •Weight less than 50 kg
结局指标
主要结局
Morphine Consumption in the First 48hours After the Operation
时间窗: 48 hours after the operation
Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.
次要结局
- Nausea Score at 48 Hours Postoperatively(48 hours after the operation)
- Total Morphine Consumption at 24hours(24 hours)
- Numerical Rating Pain Scores at 48 Hours Postoperatively(48 hours after the operation)
- Time to Resumption of Normal Diet(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
- Time to Mobilisation(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
- Time to First Flatus(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
- Time to First Request for Rescue Analgesia(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
- Nausea at 24hours Post Operatively(24 hours)
- Time to Successful Intake of Fluids(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
- Time to Medically Fit to Discharge(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
- Time to Mobilization(days)
- Time to Hospital Discharge(days)
- Time to First Bowel Motion(After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.)
研究者
Dr Nicholas Crabtree
Consultant Anaesthetist
Oxford University Hospitals NHS Trust