Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections
试验速览
- 阶段
- 不适用
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Pain intensity change in the post-operative period depending on the adopted analgesic treatment
研究概览
简要总结
Objective of the study is to compare three different analgesic techniques in patients undergoing laparoscopic colon resections: peridural catheter, patient controlled analgesia of endovenous morphine and patient controlled analgesia of sufentanil sublingual tablets.
详细描述
159 patients undergoing laparoscopic colon resections will be enrolled and randomized in three different groups.
Patients in the first group will be subjected to the positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2%99 ml+sufentanil 50 mcg at an infusion rate of 4-6 ml/h.
In the second group participants will receive an intraoperative bolus of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of endovenous morphine (injection dose 1 mg,lock-out 10 minutes,maximum morphine dosage for hour 4 mg).
In the third group the investigators will adopt an intraoperative bouls of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of sufentanil sublingual tablets( 15 mcg, lock-out 20 minutes)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 Patients undergoing laparoscopic colon resections/ Acceptance informed consent
排除标准
- •Contraindications to the positioning of a peridural catheter/ Previous allergic reactions to the drugs used in the study/ inability of using patient controlled analgesia system
研究组 & 干预措施
PERIDURAL
Peridural catheter positioning with a continuous infusion of ropivacaine 0,2% 99 ml+ sufentanil 50 mcg at an infusion rate of 4-6 ml/h
干预措施: Peridural catheter (Device)
PCA MORPHINE
Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg
干预措施: PCA Morphine (Drug)
SSTS
Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes
干预措施: Sublingual sufentanil tablet system (Device)
结局指标
主要结局
Pain intensity change in the post-operative period depending on the adopted analgesic treatment
时间窗: NRS will be evaluated in recovery room at 30 minutes after the end of surgery and at 6-24-48-72 hours after the end of surgery or until to the end of the proposed analgesic treatment
The intensity of acute post-operative pain will be evaluated ,according NRS(numerical rating scale) by our Acute pain Service.NRS is a 11 point scale for patient self-reporting of pain, where zero represents no pain and ten is considered as the worst pain ever possible
次要结局
- Side effects(The onset of possible side effects will be monitored from randomization until to the end of the proposed analgesic treatment, assessed up to 72 hours)
研究者
Marco Gemma
Principal Investigator
IRCCS San Raffaele