跳至主要内容
临床试验/NCT04981639
NCT04981639已完成3 期

Effects of Transabdominal Plane Block and Electrical Twitch Obtaining Intramuscular Stimulation on the Postoperative Pain in Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Control Trial

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2021年8月21日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
81
试验地点
2
主要终点
Pain score

研究概览

简要总结

It is important to decrease the postoperative pain in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy. We will compare the Transversus abdominis plane block with the Transversus abdominis plane block plus intramuscular electrical stimulation in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy.

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
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are able to do daily activity and walk independently.

排除标准

  • Patients with history of preoperative abdominal surgery
  • Patients who are unable to walk independently due to musculoskeletal disorder
  • Patients who are allergic to local anesthetics
  • Patients with chronic pain
  • Patients with pacemaker
  • Patients with endotracheal tube postoperatively
  • Patients with history of substance abuse
  • Patients who are unable to communicate due to mental disorder

结局指标

主要结局

Pain score

时间窗: At postoperative day 1

Pain score will be measured using visual analogue scale (0: no pain, 10: worst imaginable pain) at postoperative day 1.

次要结局

  • Pain score(At postoperative day 2, 3, 5, 7, 14 and 28)
  • IVPCA consumption(At postoperative day 1, 2, and 3)
  • Vomiting will be evaluated using 2 point scale (yes, no)(at postoperative day 1, 2, 3, 5 and 7.)
  • Peak cough flow(At postoperative day -1, 4, 7, 14, and 28)
  • Gait speed(day -1, 4, 7, 14, and 28)
  • Quality of life will be evaluated using QoR40 questionnaire (0-200)(At postoperative day 4 and 7)
  • Nausea will be evaluated using 2 point scale (yes, no)(At postoperative day 1, 2, 3, 5 and 7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Young Song

Associate Professor

Gangnam Severance Hospital

研究点 (2)

Loading locations...

相似试验

TAP and IMS for HIPEC | 临床试验