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

Study Overview
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Brief Summary
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To establish doctor-nurse-patient cooperative analgesic linkage program. 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.

Detailed Description
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Part I The establishment of doctor-nurse-patient cooperative analgesic linkage program Based on literature review and clinical investigation results, initially make a doctor-nurse-patient cooperative analgesic linkage program through discussion in experts consensus meeting. 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.

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

Conditions
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Pain, Postoperative, Anaplasia

Intervention / Treatment
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* Drug: Routine Dezocine injection
* Drug: Adjusted Dezocine injection
* Drug: Routine Dynastat or Flurbiprofen Axetil jinjection
* Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection
* Other: postoperative rehabilitation
* Drug: normal analgesia pump administration
* Drug: adjusted analgesia pump administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program. | Drug: Adjusted Dezocine injection<br>* Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.<br>* Other names: Dezocine 2;Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection<br>* Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.<br>* Other names: Dynastat or Flurbiprofen Axetil 2;Other: postoperative rehabilitation<br>* Rehabilitation was conducted at 8:00am and 2:00pm.<br>* Other names: rehabilitation;Drug: adjusted analgesia pump administration<br>* Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.<br>* Other names: analgesia pump 2;|
| Active Comparator: control group<br>Patients in the control group were received routine analgesic and functional rehabilitation. | Drug: Routine Dezocine injection<br>* Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.<br>* Other names: Dezocine 1;Drug: Routine Dynastat or Flurbiprofen Axetil jinjection<br>* Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.<br>* Other names: Dynastat or Flurbiprofen Axetil 1;Other: postoperative rehabilitation<br>* Rehabilitation was conducted at 8:00am and 2:00pm.<br>* Other names: rehabilitation;Drug: normal analgesia pump administration<br>* Dose of analgesia pump was added if needed.<br>* Other names: analgesia pump 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| movement evoked pain (Numerical rating scale) | 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. | Each rehabilitation within 3 days after surgery | 
| pain at rest (Numerical rating scale) | 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. | Each rehabilitation within 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction questionare of pain control | 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. | three days after surgery | 
| the time of first bowel movement | Record the time of first bowel movement after surgery | three days after surgery | 
| total dose of analgesics | record and calculate the total dose of analgesics | three days after surgery | 
| pain at night (Numerical rating scale) | 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. | three days after surgery | 
| adverse events during rehabilitation | adverse events during rehabilitation, such as nausea, vomiting, headache, falls | three days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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movement evoked pain, analgesia, general surgery, hepatobiliary and pancreatic disease