the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2020

Detailed Description

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.

Interventions

  • Drug: Routine Dezocine injection
    • Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
  • Drug: Adjusted Dezocine injection
    • Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.
  • Drug: Routine Dynastat or Flurbiprofen Axetil jinjection
    • Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.
  • Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection
    • Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.
  • Other: postoperative rehabilitation
    • Rehabilitation was conducted at 8:00am and 2:00pm.
  • Drug: normal analgesia pump administration
    • Dose of analgesia pump was added if needed.
  • Drug: adjusted analgesia pump administration
    • Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.

Arms, Groups and Cohorts

  • Experimental: Experimental Group
    • Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.
  • Active Comparator: control group
    • Patients in the control group were received routine analgesic and functional rehabilitation.

Clinical Trial Outcome Measures

Primary Measures

  • movement evoked pain (Numerical rating scale)
    • Time Frame: 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)
    • Time Frame: 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.

Secondary Measures

  • satisfaction questionare of pain control
    • Time Frame: three days after surgery
    • Patients answer the questionare and rate the satisfaction of pain control. The questionnaire includes 7 items indicating different aspect of pain control. Patients rate their satisfaction using score. The score ranges from 1 to 5. 1 is extremely not satisfied, 5 is extremely satisfied.
  • the time of first bowel movement
    • Time Frame: three days after surgery
    • Record the time of first bowel movement after surgery
  • total dose of analgesics
    • Time Frame: three days after surgery
    • record and calculate the total dose of analgesics
  • pain at night (Numerical rating scale)
    • Time Frame: three days after surgery
    • Asess the pain at rest during night.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.
  • adverse events during rehabilitation
    • Time Frame: three days after surgery
    • adverse events during rehabilitation, such as nausea, vomiting, headache, falls

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Caijuan Xu, master, Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Overall Contact(s)
    • Caijuan Xu, master, 057187783887, xucaijuan@zju.edu.cn

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