Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Amount of rescue analgesic used for pain relief
研究概览
简要总结
Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied using different administration techniques. The primary aim is the efficacy of the rectus sheath analgesia measured with pain ratings and the amount rescue opioid used.
Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to analgesia method used.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index over BMI <35 kg / m2
- •not pregnancy/adequate contraception
- •no contraindications to the local anaesthetic No contraindications to opioid patient controlled analgesia
- •Informed consent obtained
排除标准
- •• BMI >35 kg / m2
- •Pregnant or breast feeding
- •Contraindication to local anaesthetics
- •Contraindication to opioids
- •Not able to use patient controlled analgesia pump
- •Relaparotomy
- •No informed consent
研究组 & 干预措施
Continuous rectus sheath analgesia
Local anesthetic continuous infusion with infusion pumps
干预措施: Levobupivacaine continuous infusion (Drug)
Bolus rectus sheath analgesia
Bolus administration of local anesthetic
干预措施: levobupivacaine bolus dosing (Drug)
Single dose rectus sheath analgesia
single dose administration of local anesthetic
干预措施: single bolus of levobupivacaine (Drug)
Placebo
no rectus sheath analgesia
干预措施: Placebo (Other)
结局指标
主要结局
Amount of rescue analgesic used for pain relief
时间窗: Time 0 h up to 48 h postoperatively
From onset of rectus sheath analgesia
次要结局
- Maximum levobupivacaine plasma concentration(Time 0 h to 48 h postoperatively)
- maximum rescue analgesic concentration(time 0 h to 48 h postoperatively)