Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of laparoscopically inserted transversus abdominis plane block (LTAP) in comparison to local wound analgesia in laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.
详细描述
The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacain and wound infiltration with placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA). Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6 month follow-up survey regarding pain and general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of 1:1.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
- •ASA class 1-3
- •Patient is capable of giving informed consent
排除标准
- •Obstructive sleep apnea
- •ASA class >4
- •Other significant risks associated with opioid use
- •Contraindications for local anesthetics or NSAIDs
- •Regular opioid consumption before operation
结局指标
主要结局
Postoperative opioid consumption
时间窗: 24 hours
Oxicodone consumption measured via PCA-pump in Morphine equivalents
次要结局
- Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)(6 months postop)
- Postoperative pain assessed by NRS (numeric rating scale)(Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively)
- Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)(6 months postop)
- Intra- or postoperative complications(Up to 6 months postop)
研究者
Anna Terho
Principal Investigator
Oulu University Hospital