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2017-11-01
2020-08-01
2020-10-01
80
NCT03823846
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
INTERVENTIONAL
the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-01-23 | N/A | 2020-02-11 |
2019-01-28 | N/A | 2020-02-12 |
2019-01-31 | N/A | 2019-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Experimental Group Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program. | DRUG: Adjusted Dezocine injection
DRUG: Adjusted Dynastat or Flurbiprofen Axetil jinjection
OTHER: postoperative rehabilitation
DRUG: adjusted analgesia pump administration
|
| ACTIVE_COMPARATOR: control group Patients in the control group were received routine analgesic and functional rehabilitation. | DRUG: Routine Dezocine injection
DRUG: Routine Dynastat or Flurbiprofen Axetil jinjection
OTHER: postoperative rehabilitation
DRUG: normal analgesia pump administration
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Caijuan Xu, master Phone Number: 057187783887 Email: xucaijuan@zju.edu.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
