NCT02225418撤回不适用
Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.
Jens Borglum Neimann1 个研究点 分布在 1 个国家开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Pain score in sitting position
研究概览
简要总结
The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.
The trial will compare active TQL block versus placebo TQL block after said operation.
The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for elective laparoscopic cholecystectomy
- •received oral and written information about the trial
- •American Society of Anaethesiologists (ASA) classification 1-3
- •NRS score > 3 upon arrival at the PACU area
排除标准
- •Cannot cooperate
- •Does not speak or understand Danish
- •Allergy towards drugs used in the trial
- •Large daily consumption of opioids
- •Known alcohol og medicin abuse
- •Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
- •Pregnancy
研究组 & 干预措施
Placebo TQL block
Sham Comparator
30 ml single shot TQL block with saline 0,9%
干预措施: saline (Drug)
Active TQL block
Active Comparator
30 ml single shot TQL block with ropivacaine 0,75%
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain score in sitting position
时间窗: 1 hour
Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
次要结局
- Pain score at rest(15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour)
- Total opioid consumption in PACU area(On average 3 hours)
- Opioid side effects (nausea, vomiting)(On average 3 hours)
- Length of stay in PACU area(On average 3 hours)
- Pain score at sitting position(15 min 30 min 2 hour 3 hour 4 hour 5 hour)
研究者
Jens Borglum Neimann
Associate professor
Bispebjerg Hospital
研究点 (1)
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