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

Not Applicable

• Conditions: Pain, Postoperative; Anaplasia
• Interventions: Drug: Adjusted Dezocine injection; Drug: Routine Dezocine injection; Drug: Routine Dynastat or Flurbiprofen Axetil jinjection; Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection; Other: postoperative rehabilitation; Drug: adjusted analgesia pump administration; Drug: normal analgesia pump administration

• Registration Number: NCT03823846
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-31
• Status Verified: 2019-04
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-08-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Adjusted Dezocine injection	Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.
Experimental Group	postoperative rehabilitation	Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.
Experimental Group	adjusted analgesia pump administration	Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.
control group	Routine Dezocine injection	Patients in the control group were received routine analgesic and functional rehabilitation.
control group	Routine Dynastat or Flurbiprofen Axetil jinjection	Patients in the control group were received routine analgesic and functional rehabilitation.
control group	postoperative rehabilitation	Patients in the control group were received routine analgesic and functional rehabilitation.
control group	normal analgesia pump administration	Patients in the control group were received routine analgesic and functional rehabilitation.
Experimental Group	Adjusted Dynastat or Flurbiprofen Axetil jinjection	Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.

Primary Outcome Measures

Name	Time	Method
movement evoked pain (Numerical rating scale)	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)	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 Outcome Measures

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

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China