Randomised Double Blind Trial to Investigate the Effects of Intraperitoneal Local Anaesthetic Following Colonic Surgery.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post operative recovery using the Identity consequence fatigue scale (ICFS)
研究概览
简要总结
Aim:
The general aim of this research group is to improve the recovery of patients after abdominal surgery. The specific aim of this study is to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia application on postoperative pain and post-operative fatigue. This will be conducted in the setting of an enhanced recovery after surgery program (ERAS).
Methods:
Patients will be randomised by computer generated random numbers and opaque envelope method. In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9% saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at 4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of postoperative pain will be performed by visual analogue scale, and fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at various intervals post-operatively. Blood tests for inflammatory markers including glucose, cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be taken.
Significance to health:
This method of analgesia administration has not been investigated in open major colonic surgery. This trial has wide reaching implications, with the potential to improve pain and thus recovery after abdominal surgery.
详细描述
Scientific Background:
Postoperative fatigue (POF) is a common phenomenon following abdominal surgery and is currently under investigation at the department of surgery, Middlemore hospital, Auckland. POF in patients undergoing major abdominal procedures is very common. It has been reported that 92% of patients who have undergone abdominal surgery report increased fatigue reports immediately after the procedure, dropping to about 10% in 3 months. POF comprises of unpleasant symptoms that impact on the patient's quality of life.
- It can create difficulties in performing activities of daily living.
- The symptoms of POF include tiredness, lack of energy and sense of debilitating muscle weakness.
- POF is thought to be associated with poor physical, psychological and functional outcomes.
- The aetiology of POF is thought to be multi-factorial. Biological, psychological and social factors all contribute.
The biological aspect of POF can be divided into the physiological stress response to the trauma of surgery, postoperative nutritional deficits and the loss of previous cardiovascular fitness subsequently after surgery. Various methods have been investigated over the last two decades to address and "dampen" the physiological response in order to enhance postoperative recovery.
There are two possible ways of communication between the periphery and the brain. One is the hormonal route and the other is the neural route. The later route is projected via paracrine action of local cytokines on the afferent nerve endings 5. In the abdominal cavity, there are two types of afferent endings 6. These are the vagal afferents and spinal afferents. Vagal and spinal afferent fibres transmit sensory information from the GI tract to the CNS. Afferents from the vagus nerve conduct neuronal messages from the intra-peritoneal cavity to the CNS.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Consecutive patients undergoing open colonic resection at MSC under the ERAS program.
排除标准
- •Known sensitivity to the local anaesthetic agents
- •Patients who prefer not to participate (no consent gained)
- •ASA greater or equal to 4
- •Rectal resection
- •Formation of stoma
- •Current use of systemic steroids
研究组 & 干预措施
LA
Use of Ropivacaine
干预措施: Ropivacaine (Drug)
Placebo
Use of 0.9% saline
干预措施: 0.9% Saline (Drug)
结局指标
主要结局
Post operative recovery using the Identity consequence fatigue scale (ICFS)
时间窗: Base-line, Day 1, Day 3, Day 7, Day 14, Day 30, Day 60
次要结局
- Post-operative rest, movement and cough pain using Visual analogue score(2,4,6,8,12,24,48,72 hours and on day 7)
- Post operative analgesia use using morphine equivalence data(Total use on day 1, day 2, day 3 post operatively and total use until discharge)
- Serum Ropivacaine level, serum Cytokine, serum Cortisol, serum glucose and serum CRP. Albumin, haematological parameters and biochemical parameters.(Pre-operatively, 8, 20, 48,72 hours post operatively)
- Questions aimed at symptoms of local anaesthetic toxicity(2, 4, 6, 8, 12, 24, 48, 72 hours post operatively)
- Recovery of bowel function measured by time to pass flatus and time to pass stool post-operatively.(Assessed at 2, 4, 6, 8, 12, 24, 36, 48, 60, 72 hours.)
- Quality of care assessment based on a 100mm visual analogue scale (1-10).(pre-op, day1, day 2, day3, day 7, day 30 and day 60 post operatively)