Randomised Comparison Between Spinal/GA or GA Alone Following Robot-assisted Laparoscopic Prostatectomy. Stress Response, Pain, Recovery and Home Discharge
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Number of patients ready for home discharge at 8 pm after surgery
研究概览
简要总结
Prostate cancer is the commonest cancer form in men in Northern Europe. Management of the cancer often includes surgical removal of the primary tumor. In the last 5-10 years, robot assisted laparoscopic prostatectomy (RALP) has become common. Good pain relief is central to early mobilization and greater patient satisfaction. Randomized controlled studies on pain relief following RALP are few and the role of spinal analgesia in pain management following robotic surgery has not been described. Techniques available for pain relief following RALP include spinal anesthesia with or without opiates, intravenous analgesia with morphine or a multimodal pain management technique using a combination of several analgesics. Spinal anesthesia and analgesia reduces the surgical stress and inflammatory response following laparoscopic colorectal surgery and may offer similar benefit even during RALP.
Early perioperative complications may cause postoperative morbidity following robotic surgery, and sometimes delay home discharge. Since all robotic operations in the pelvic region are performed in a deep Trendelenberg position, this can even have negative consequences for the heart, brain and the lungs. Cardiac complications in the form of minimal cardiac injury or mild heart failure have not been previously studied following RALP. Additionally, patients are sometimes delirious in the early postoperative period following RALP. The precise cause for this remains unclear and may be related to pain, cognitive dysfunction or an urge to pass urine despite a urinary catheter.
In addition to good postoperative pain relief, early postoperative mobilization and home discharge are important milestones in recovery of full function following major surgery. With improvement in surgical technique, the time has come to evaluate if RALP can be performed on an ambulatory basis. The main aims of this study are:
- Can RALP be performed on an ambulatory basis and patients ready to be discharged home at 8 pm?
- To determine if spinal anesthesia reduces pre-discharge pain intensity, stress response and other perioperative side effects.
- Is sufentanil or fentanyl the analgesic of choice when administered spinally together with bupivacaine as an analgesic.
- To determine the frequency and severity of cardiac and respiratory complications in the steep Trendelenberg position during RALP.
- To assess the quality of recovery, quality of life and activities of daily living following ambulatory RALP?
详细描述
Prospective, randomized study blinded to observers (spinal or no-spinal). All formal approvals will be obtained from different authorities prior to study start. It will be registered in an international database (clinicaltrials.gov).
Patients > 18 years, ASA I-III, undergoing RALP will be included into the study. Patients on chronic opiate medication, those with contraindications to spinal anesthesia or allergy to any component drugs used during spinal anesthesia or other analgesics used in the study will be excluded. Patients living alone or having no adult at home to look after them during the first 24 h after home discharge will also be excluded. Informed written consent will be obtained from all patients. On the morning of surgery, all patients will receive paracetamol 1 g orally 1 h before planned surgery, and will be randomized to one of two groups as shown below:
Robot-assisted laparoscopic prostatectomy (RALP) (morning surgery)
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Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management
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Group SF (Spinal/Fentanyl): Spinal anesthesia with bupivacaine 12.5 mg+fentanyl 15 ug Robot-assisted laparoscopic prostatectomy (RALP) (afternoon surgery)
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Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management 2. Group SS (Spinal/Sufentanil): Spinal anesthesia with bupivacaine 12.5 mg+sufentanil 5 ug
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
- Single (Outcomes Assessor)
盲法说明
Outcome observer blinded to method of analgesia (spinal/no-spinal)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Elective robot-assisted laparoscopic prostatectomy Karolinska Hospital
排除标准
- •Communication limitations (language, mental)
- •Chronic opiate use
- •Allergy to NSAID
- •Coagulation problems preventing administration of spinal analgesia
研究组 & 干预措施
Analgesics, multimodal
Combination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics
干预措施: Analgesics (Drug)
Bupivacaine
Spinal anesthetic with bupivacain + fentanyl/sufentanil
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Number of patients ready for home discharge at 8 pm after surgery
时间窗: With 12 h of surgery start
Number of patients ready to be discharged home after surgery when using a standardized home-discharge criteria
次要结局
- Pain intensity(7 days postoperatively)
- Amount (mg) of morphine administered as rescue analgesic at 12 and at 24 h(At 12 hours and 24 hours postoperatively)
- Stress markers in plasma(24 hours)
- Quality of Recovery(3 days postoperatively)
- Quality of life after surgery(30 days postoperatively)
研究者
Anil Gupta
Associate Professor
Karolinska Institutet