Comparison of Intrathecal Morphine, Epidural Bupivacaine With Sufentanil and Systemic Patient Controlled Analgesia With Morphine for Analgesia After Colorectal Surgery: Prospective Randomised Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Non-inferiority of analgesia with intrathecal morphine 0.3mg compared with epidural mixture bupivacaine 0.125% and sufentanil 0,4ug/ml.
研究概览
简要总结
The purpose of this study is to determine which postoperative analgesia is optimal after colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural analgesia and standard systemic analgesia. All patients will have the possibility to administer themselves intravenous morphine as needed.
详细描述
Introduction
Colorectal surgery is a frequent operation with expected strong post-operative pain. Thoracic epidural analgesia is a preferred method by many authors, but it is not without risks. As patients in our hospital usually stay at a surgical ICU for 24 hours only and epidural infusion of opioids is prohibited at standard wards according to our hospital standards, it seems to be too demanding method. Systemic analgesia with strong opioids is usually an alternative, but high doses of opioids are known to cause side effects. The last possibility is a single-shot intrathecal injection of morphine which demonstrated long-lasting analgesia after various procedures. The main advantage is easy technique, absence of catheters and low cost. There are not enough studies to decide which method is the most convenient. The purpose of this prospective randomized open clinical study is to determine which postoperative analgesia is optimal after colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural analgesia and compare both methods to standard systemic analgesia. All patients will have the possibility to administer themselves intravenous morphine as needed.
Hypotheses
- Intrathecal morphine is non-inferior to continuous epidural analgesia
- ] Intrathecal morphine will decrease the need for i.v. systemic patient controlled analgesia (PCA) with morphine
Aims of the study
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with elective colorectal surgery (left or right hemicolectomy, subtotal colectomy, resection of sigmoid, rectal or cecum)
排除标准
- •Known allergy to any of drugs used, coagulopathy, sepsis, cognitive dysfunction and/or inability to understand instruction.
- •Pregnancy (is assessed as a part of pre-operative examination).
- •Abuse of drugs or morphine therapy before surgery.
- •Idiopathic bowel disease.
研究组 & 干预措施
Morphine intrathecal
An intrathecal administration of preservative-free morphine 0.3 mg in 3 ml NS prepared in a sterile ampoules by a hospital pharmacy will be performed before induction of anaesthesia in a sitting position between L2 and L3 - L4/L5 vertebrae. Standard general anaesthesia will be performed. After surgery, the patients will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out interval 5 min for 3 days at a surgical ICU.
干预措施: Morphine intrathecal (Drug)
Morphine intrathecal
An intrathecal administration of preservative-free morphine 0.3 mg in 3 ml NS prepared in a sterile ampoules by a hospital pharmacy will be performed before induction of anaesthesia in a sitting position between L2 and L3 - L4/L5 vertebrae. Standard general anaesthesia will be performed. After surgery, the patients will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out interval 5 min for 3 days at a surgical ICU.
干预措施: Morphine intravenous (Drug)
Bupivacaine + Sufentanil epidural
An epidural catheter will be inserted before induction of anaesthesia in a sitting position between T9 and T10 - T12 and L1 vertebrae. A test dose of 4 ml 0.5 bupivacaine will be administered to rule out intravascular injection or subarachnoid or subdural block. Standard general anaesthesia will be performed. Thirty minutes before the end of the surgery, patients will be administered a bolus of a mixture of bupivacaine 0.5% (3 ml) + sufentanil 10 mcg (2 ml) + NS 5 ml followed by a continuous infusion of a mixture containing in 1 ml bupivacaine 0,125% and sufentanil 0,4 mcg at 8 ml/h. At the same time patients will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out interval 5 min for 3 days at a surgical ICU.
干预措施: Bupivacaine + Sufentanil epidural (Drug)
Bupivacaine + Sufentanil epidural
An epidural catheter will be inserted before induction of anaesthesia in a sitting position between T9 and T10 - T12 and L1 vertebrae. A test dose of 4 ml 0.5 bupivacaine will be administered to rule out intravascular injection or subarachnoid or subdural block. Standard general anaesthesia will be performed. Thirty minutes before the end of the surgery, patients will be administered a bolus of a mixture of bupivacaine 0.5% (3 ml) + sufentanil 10 mcg (2 ml) + NS 5 ml followed by a continuous infusion of a mixture containing in 1 ml bupivacaine 0,125% and sufentanil 0,4 mcg at 8 ml/h. At the same time patients will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out interval 5 min for 3 days at a surgical ICU.
干预措施: Morphine intravenous (Drug)
Morphine intravenous
Patients will be administered standard general anaesthesia. After surgery, bolus doses of morphine 2 mg will be administered until level of pain will be < 4 (VAS 0 - 10). Analgesia will be continued by PCA device using morphine, bolus dose 1 mg, lock-out interval 5 min. for 3 days at surgical ICU.
干预措施: Morphine intravenous (Drug)
结局指标
主要结局
Non-inferiority of analgesia with intrathecal morphine 0.3mg compared with epidural mixture bupivacaine 0.125% and sufentanil 0,4ug/ml.
时间窗: Within the first 3 days after surgery
Non-interiority is defined as difference in morphine consumption during patient-controlled analgesia no more than 10%
Better analgesia after intrathecal morphine compared to systemic analgesia with morphine
时间窗: Within the first 3 days after surgery
Lower consumption of PCA morphine in patients with intrathecal morphine compared to systemic analgesia with PCA morphine only.
次要结局
- Pain intensity(Within the first 3 days after surgery)
- Side effects of intrathecal morphine compared to epidural or systemic analgesia(Within the first 3 days after surgery)
研究者
Jiri Malek
Assoc. Prof. MD, Ph.D.
Charles University, Czech Republic