跳至主要内容
临床试验/NCT03823846
NCT03823846Unknown不适用

The Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain After Laparotomy for Patients With Hepatobiliary and Pancreatic Disease

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
movement evoked pain (Numerical rating scale)

研究概览

简要总结

  1. To establish doctor-nurse-patient cooperative analgesic linkage program.
  2. Evaluate the effect of doctor-nurse-patient cooperative analgesic linkage program on movement evoked pain after laparotomy for patients with hepatobiliary and pancreatic disease through quasi-experimental study.

详细描述

Part I The establishment of doctor-nurse-patient cooperative analgesic linkage program

  1. Based on literature review and clinical investigation results, initially make a doctor-nurse-patient cooperative analgesic linkage program through discussion in experts consensus meeting.
  2. Using Delphi method, determine the doctor-nurse-patient cooperative analgesic linkage program after two rounds consultation.

Part II Clinical application study of doctor-nurse-patient cooperative analgesic linkage program.

Conduct non-randomized control study in corresponding period. 80 patients from two wards which managed by the same medical and nursing team were divided into experimental and control group. Patients in the control group were received routine post-operative analgesia pump and analgesics, and functional rehabilitation, while ones in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program. Evaluate the effect of pain control during rehabilitation, adverse events during rehabilitation, patients' satisfaction of pain control.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Consent to the study.
  • Normal cognitive ability and speak Chinese
  • Patients received selective laparotomy under general anesthesia.
  • Length of stay is longer than three days.
  • Patients who are allowed to do rehabilitation.

排除标准

  • Patients with Severe organic disease, chronic pain, history of brain injury, history of drug or alcohol addiction.
  • Psychiatric patients
  • Consciousness disorder
  • Patients contradict to opioid medications

研究组 & 干预措施

Experimental Group

Experimental

Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.

干预措施: postoperative rehabilitation (Other)

Experimental Group

Experimental

Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.

干预措施: Adjusted Dezocine injection (Drug)

Experimental Group

Experimental

Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.

干预措施: Adjusted Dynastat or Flurbiprofen Axetil jinjection (Drug)

Experimental Group

Experimental

Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.

干预措施: adjusted analgesia pump administration (Drug)

control group

Active Comparator

Patients in the control group were received routine analgesic and functional rehabilitation.

干预措施: Routine Dezocine injection (Drug)

control group

Active Comparator

Patients in the control group were received routine analgesic and functional rehabilitation.

干预措施: Routine Dynastat or Flurbiprofen Axetil jinjection (Drug)

control group

Active Comparator

Patients in the control group were received routine analgesic and functional rehabilitation.

干预措施: postoperative rehabilitation (Other)

control group

Active Comparator

Patients in the control group were received routine analgesic and functional rehabilitation.

干预措施: normal analgesia pump administration (Drug)

结局指标

主要结局

movement evoked pain (Numerical rating scale)

时间窗: Each rehabilitation within 3 days after surgery

Assess movement evoked pain during rehabilitation. Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.

pain at rest (Numerical rating scale)

时间窗: Each rehabilitation within 3 days after surgery

Assess pain at rest before rehabilitation.Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.

次要结局

  • satisfaction questionare of pain control(three days after surgery)
  • the time of first bowel movement(three days after surgery)
  • total dose of analgesics(three days after surgery)
  • adverse events during rehabilitation(three days after surgery)
  • pain at night (Numerical rating scale)(three days after surgery)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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