NCT02949778已完成4 期
Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Physical Classification Status (ASA) I-II
- •Age 18 to 64
- •Weight above or equal to 60 kg
- •Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
- •Patient is expected able to cooperate during the treatment and follow up.
- •Signed informed consent obtained and documented according to the International Conference on Harmonization (ICH) good clinical practice (GCP), and national/local regulations.
排除标准
- •A history of anaphylactic shock
- •Cardiovascular disease other than hypertension and/or hyperlipidemia
- •Known allergy to ropivacaine or morphine
- •A history of chronic pain
- •Psychiatric comorbidity
- •Scheduled opioid pain medication or neuroleptic drugs
- •Coagulation disorders or treatment with platelet inhibitors
- •Pregnancy or breastfeeding
- •Treatment with class III antiarrhythmics, sertindole, ziprasidone, amisulpride, ceritinib, hydroxyzine, fluvoxamine
- •Any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).
研究组 & 干预措施
Ropivacaine 3.75mg/mL
Active Comparator
QL-block using 20 mL ropivacaine 3.75mg/mL
干预措施: QL-block (Procedure)
Ropivacaine 3.75mg/mL
Active Comparator
QL-block using 20 mL ropivacaine 3.75mg/mL
干预措施: Ropivacaine (Drug)
Sodium chloride 9 mg/mL
Placebo Comparator
QL-block using 20 mL sterile sodium chloride 9 mg/mL
干预措施: QL-block (Procedure)
Sodium chloride 9 mg/mL
Placebo Comparator
QL-block using 20 mL sterile sodium chloride 9 mg/mL
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 24 hours
total opioid consumption the first 24 postoperative hours
次要结局
未报告次要终点
研究者
研究点 (1)
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