NCT00413127终止2 期
Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration
University Hospital Muenster3 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- length of postoperative hospital stay
研究概览
简要总结
The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective colorectal surgery
排除标准
- •history of anti-inflammatory therapy
- •history of inflammatory bowl diseases
- •history of chronic pain treatment
研究组 & 干预措施
1
Experimental
Lidocaine i.v
干预措施: lidocaine (Drug)
2
Active Comparator
intraoperatively lidocaine epidural postoperatively lidocaine i.v.
干预措施: lidocaine (Drug)
3
Active Comparator
intraoperatively lidocaine i.v. postoperatively lidocaine epidural
干预措施: lidocaine (Drug)
4
Active Comparator
lidocaine epidural
干预措施: lidocaine (Drug)
5
Placebo Comparator
placebo i.v.
干预措施: NaCl 0,9% (Drug)
结局指标
主要结局
length of postoperative hospital stay
时间窗: end of hospital stay
次要结局
- Postoperative Analgesia(until end of hospital stay)
- Hyperalgesia perioperative(postoperative day 2, 4, 8, end of hospital stay and follow-up)
- Cytokine levels perioperative(before surgery and 4 hours, 2 and 4 days after surgery)
- Bowel motility perioperative(days after surgery)
- Length of PACU stay(end of PACU stay)
- Cognitive function perioperatively(before surgery, one and four days after surgery, at end of hospital stay and follow-up)
- Incidence of wound healing disturbances(within 4 weeks after surgery)
研究者
研究点 (3)
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Perioperative protective effects of lidocaine - clinical study on the route and timing of administratiopatients, scheduled for major elective colorectal surgeryMedDRA version: 14.0Level: LLTClassification code 10040668Term: Sigmoid hemicolectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: PTClassification code 10009879Term: Colectomy totalSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: PTClassification code 10059848Term: ProctocolectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10019460Term: HemicolectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10039153Term: Right hemicolectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10024107Term: Left hemicolectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: PTClassification code 10063950Term: IleocolectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: PTClassification code 10042609Term: SurgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: PTClassification code 10061778Term: ColectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10044083Term: Total colectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10009878Term: Colectomy partialSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10009880Term: Colectomy transverseSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10033684Term: PanproctocolectomySystem Organ Class: 10042613 - Surgical andEUCTR2007-000259-33-DEDepartment of Anesthesiology and Intensive Care, University Hospital Münster
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