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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
I (IVPCA)
Intravenous patient controlled analgesia will be performed.
干预措施: IVPCA (Procedure)
II (IVPCA+TAP)
Intravenous patient controlled analgesia and transversus abdominis plane block will be performed.
干预措施: TAP (Procedure)
III (IVPCA, IMS, and TAP)
Intravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed.
干预措施: IMS (Procedure)
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
Young Song
Associate Professor
Gangnam Severance Hospital