2024-513406-59-00招募中3 期
PRO_RSTAP study: Effect of medial transversus abdominis plane (TAP) block and rectus sheath block on inguinal hernia surgery recovery, a prospective randomized double-blind study
Pirkanmaan hyvinvointialue2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Equivalent morphine consumption in the perioperative period and after surgery, divided in: Intraoperative period, the immediate postoperative period, defined as the time between discharge from the operating room and discharge from the hospital and seven postoperative days
研究概览
简要总结
To assess the efficacy of combined RS and TAP blocks in open inguinal hernia surgery and to analyze whether using RS+TAP blocks is beneficial to using a TAP block only
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Able to give a written informed consent, Aged 18 years or older at screening, Diagnosed with Inguinal hernia scheduled for open inguinal hernia surgery, Adequate Finnish language literacy, Unilateral surgery
排除标准
- •Surgery that is planned to be performed under general or spinal anesthesia, Allergy or hypersensitivity to study medications or their ingredients, Pregnancy or breast-feeding, aim of becoming pregnant during the study, Inability to provide written informed consent, Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study, A history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements, Prior or concurrent malignancy, Surgery that was not planned as day surgery, Bilateral surgery, Additional surgery to inguinal hernioplasty, Age under 18 years, Inability to give informed consent, Patient refusal, Chronic pain or prior opioid medication, Psychiatric disorder as defined by: medication used
结局指标
主要结局
Equivalent morphine consumption in the perioperative period and after surgery, divided in: Intraoperative period, the immediate postoperative period, defined as the time between discharge from the operating room and discharge from the hospital and seven postoperative days
Equivalent morphine consumption in the perioperative period and after surgery, divided in: Intraoperative period, the immediate postoperative period, defined as the time between discharge from the operating room and discharge from the hospital and seven postoperative days
次要结局
- postoperative pain, as defined by numerical rating scale (NRS), patient opinion of the efficacy of the pain treatment, postoperative nausea and vomiting (PONV), as defined as use of postoperative nausea medications, use of rescue analgesia, rescue hospitalization, intra- and postoperative durations, intraoperative anesthetic methods, analysis of patient flow and, anesthesiologic and surgical complications, depression and anxiety as measured by BDI and STAI queries
研究者
Aki Lumme
Scientific
Pirkanmaan hyvinvointialue
研究点 (2)
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