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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823846
• Other study ID #: 2017-084
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: April 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Caijuan Xu, master
• Phone: 057187783887
• Email: xucaijuan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaplasia
• Pain, Postoperative
• Pancreatic Diseases

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	the time of first bowel movement	Record the time of first bowel movement after surgery	three days after surgery
Secondary	total dose of analgesics	record and calculate the total dose of analgesics	three days after surgery
Secondary	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
Secondary	adverse events during rehabilitation	adverse events during rehabilitation, such as nausea, vomiting, headache, falls	three days after surgery