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临床试验/NCT04352023
NCT04352023Unknown2 期

Comparison of Analgesic Efficacy After Major Surgery in Pancreatobiliary Cancers: Intravenous Patient-controlled Analgesia Versus Patient-controlled Epidural Analgesia

National Cancer Center, Korea3 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
110
试验地点
3
主要终点
Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia

研究概览

简要总结

Prospective, single institute based, open label, double arm, randomized controlled trial Hypothesis: Pain control after resection of hepatobiliary tumors in patients with PCEA is more effective than in patients with IV-PCA.

详细描述

Postoperative pain control is important in helping patients who underwent abdominal surgery to recover and to live a normal life. There is a method of administering painless injections to relieve postoperative pain. Currently, IV-PCA is mostly used. However, this method has a disadvantage in that the dosage of the opioid-based analgesic is increased, and thus side effects may be concerned. By administering analgesics through an epidural route approached through the thoracic vertebrae rather than intravenous injection, effective post-operative pain control and less side effects can be expected in lesser amounts. This study prospectively compared the pain control effects of IV-PCA and PCEA in patients undergoing resection of hepatobiliary tumors at the National Cancer Center, revealing that PCEA is more effective in alleviating pain after surgery. It has a purpose. In addition, the investigators will investigate and compare clinical outcomes (first fart, dietary progression, postoperative complications, etc.) of the two patient groups and investigate the side effects of PCEA and complications related to the procedure.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

2, 4, 6 block randomization

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pancreatobiliary malignancies
  • Anticipating open surgery
  • Written concent

排除标准

  • History of previous upper abdominal open surgery
  • Psychiatric problems
  • Cognitive impairment
  • Chronic pain
  • Elimination Criteria
  • Rejected written concent
  • Failure to follow instructions of doctor
  • Stopped surgery due to peritoneal metastasis

结局指标

主要结局

Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia

时间窗: Day 2 postoperatively

Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during ambulation on the day 2 postoperatively; Scale 0 means no pain and scale 10 means most painful

次要结局

  • Investigation and comparison of pain and clinical progress during rest after surgery, side effects of drugs administered to IV-PCA and PCEA, and complications related to PCEA procedure(7 days)

研究者

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

Sang-Jae Park

Research Director

National Cancer Center, Korea

研究点 (3)

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