A Randomised Controlled Trial of Thoracic Epidural Analgesia Versus Surgically Placed Rectus Sheath Catheters for Open Radical Cystectomy: Is There a Difference in Patient Outcomes?
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cumulative post-operative opioid consumption
研究概览
简要总结
This is a prospective randomised controlled trial that will compare the outcomes of rectus sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower midline abdominal incision for bladder cancer.
详细描述
This study will compare the outcomes of two different pain control techniques, used as standard of care, following major abdominal surgery for bladder removal. Rectus sheath catheters are small tubes that are positioned into a specific area of the cut abdominal wall at the end of surgery; whereas an epidural is a tube that is positioned into the back. Both allow administration of local anaesthetic for pain control. The current gold standard is an epidural. This study will aim to evaluate this and show the comparative efficacy of the rectus sheath catheter, which anecdotally the investigators have found superior in practice.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over or equal to the age of 19 years old who can understand the study protocol and are able to give consent
- •Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
- •Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30mg morphine equivalents
- •Patients must be able to understand and be able to use patient controlled analgesia
- •Patients must be undergoing a cystectomy with an infra-umbilical midline incision
排除标准
- •Patients with BMI greater than 40
- •Patients with an allergy to local anaesthetics
- •Patients who are contraindicated to having an epidural (e.g. coagulopathic, distorted anatomy, patient refusal, infection at the site of proposed insertion)
- •Patients with previous spinal surgery at the proposed site of epidural
- •Patients with neurodegenerative disorders or spinal cord injury
- •Patients with known anatomy that would not permit placement of the rectus sheath catheters e.g. Prune Belly Syndrome
- •Patients undergoing another complex abdominal procedure in addition to cystectomy and reconstruction requiring extension of the abdominal incision above the umbilicus.
研究组 & 干预措施
Rectus Sheath Catheter Group
Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour.
干预措施: Rectus Sheath Catheters (Device)
Epidural Group
Patients will have a standard epidural placement with infusion of 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response
干预措施: Epidural (Device)
结局指标
主要结局
Cumulative post-operative opioid consumption
时间窗: To Day 3 post-op
次要结局
- Length of Hospital Stay(The day at which patient is discharged from hospital- usually on average 10 days post-operatively)
- Patient Satisfaction with pain control(Day 3 post operatively)
- Duration of post-operative ileus(This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.)
- Time to mobilisation(The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively)
- Total patient fluid requirements throughout hospital admission(From the start of the operation to day 3 post-operatively.)
- Patient total intraoperative Opioid requirement(Intraoperatively)
- Recorded evidence of hypotension(Until Day 3 postoperatively)
- Visual Analogue Score pain score(within 4 hours post-operatively and on days 1, 2 and 3 post-operatively)
- Complications and side effects.(30 day morbidity and mortality)
研究者
Dr. Alan I. So
Urologic Surgeon
Vancouver Coastal Health