Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) vs Sole Local Wound Infiltration in LCC (Laparoscopic CholeCystectomy) - Double-blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 2
- 主要终点
- cumulative opioid consumption during the stay at the recovery
研究概览
简要总结
This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC.
There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block.
We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big.
The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be blinded to patients and recovery room personnel, as well as the ward nurses and physicians, but not to operating surgeon(s), anesthesiologist(s), and nurses, treating patients during the surgery.
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
- •All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.
排除标准
- •Age under 18 years, chronic daily opioid and/or pain tolerance / pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.
结局指标
主要结局
cumulative opioid consumption during the stay at the recovery
时间窗: duration of stay at the recovery (estimated 1-4 hours)
all groups; mg, morphine equivalent
次要结局
- cumulative opioid consumption (emergency and inpatient surgery)(while admitted; est. 2 days)
- maximum NRS score during the day of surgery, after discharge (daycare / outpatient)(30 min after surgery, every 60 min afterwards; 2 days)
研究者
Roman Kornosev
MD
Helsinki University Central Hospital