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

February 11, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • 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
Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.
Other Names:
  • Dezocine 2
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 Names:
  • Dynastat or Flurbiprofen Axetil 2
Other: postoperative rehabilitation
Rehabilitation was conducted at 8:00am and 2:00pm.
Other Names:
  • rehabilitation
Drug: adjusted analgesia pump administration
Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.
Other Names:
  • analgesia pump 2
ACTIVE_COMPARATOR: control group
Patients in the control group were received routine analgesic and functional rehabilitation.
Other: postoperative rehabilitation
Rehabilitation was conducted at 8:00am and 2:00pm.
Other Names:
  • rehabilitation
Drug: Routine Dezocine injection
Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
Other Names:
  • Dezocine 1
Drug: Routine Dynastat or Flurbiprofen Axetil jinjection
Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.
Other Names:
  • Dynastat or Flurbiprofen Axetil 1
Drug: normal analgesia pump administration
Dose of analgesia pump was added if needed.
Other Names:
  • analgesia pump 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each rehabilitation within 3 days after surgery
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.
Each rehabilitation within 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three days after surgery
the time of first bowel movement
Time Frame: three days after surgery
Record the time of first bowel movement after surgery
three days after surgery
total dose of analgesics
Time Frame: three days after surgery
record and calculate the total dose of analgesics
three days after surgery
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.
three days after surgery
adverse events during rehabilitation
Time Frame: three days after surgery
adverse events during rehabilitation, such as nausea, vomiting, headache, falls
three days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Caijuan Xu, master, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

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 Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (ACTUAL)

January 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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