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

Primary Purpose

Pain, Postoperative, Anaplasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine Dezocine injection
Adjusted Dezocine injection
Routine Dynastat or Flurbiprofen Axetil jinjection
Adjusted Dynastat or Flurbiprofen Axetil jinjection
postoperative rehabilitation
normal analgesia pump administration
adjusted analgesia pump administration
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring movement evoked pain, analgesia, general surgery, hepatobiliary and pancreatic disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

control group

Arm Description

Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.

Patients in the control group were received routine analgesic and functional rehabilitation.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
the time of first bowel movement
Record the time of first bowel movement after surgery
total dose of analgesics
record and calculate the total dose of analgesics
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.
adverse events during rehabilitation
adverse events during rehabilitation, such as nausea, vomiting, headache, falls

Full Information

First Posted
January 23, 2019
Last Updated
February 11, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03823846
Brief Title
the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anaplasia
Keywords
movement evoked pain, analgesia, general surgery, hepatobiliary and pancreatic disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients in the control group were received routine analgesic and functional rehabilitation.
Intervention Type
Drug
Intervention Name(s)
Routine Dezocine injection
Other Intervention Name(s)
Dezocine 1
Intervention Description
Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
Intervention Type
Drug
Intervention Name(s)
Adjusted Dezocine injection
Other Intervention Name(s)
Dezocine 2
Intervention Description
Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.
Intervention Type
Drug
Intervention Name(s)
Routine Dynastat or Flurbiprofen Axetil jinjection
Other Intervention Name(s)
Dynastat or Flurbiprofen Axetil 1
Intervention Description
Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.
Intervention Type
Drug
Intervention Name(s)
Adjusted Dynastat or Flurbiprofen Axetil jinjection
Other Intervention Name(s)
Dynastat or Flurbiprofen Axetil 2
Intervention Description
Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.
Intervention Type
Other
Intervention Name(s)
postoperative rehabilitation
Other Intervention Name(s)
rehabilitation
Intervention Description
Rehabilitation was conducted at 8:00am and 2:00pm.
Intervention Type
Drug
Intervention Name(s)
normal analgesia pump administration
Other Intervention Name(s)
analgesia pump 1
Intervention Description
Dose of analgesia pump was added if needed.
Intervention Type
Drug
Intervention Name(s)
adjusted analgesia pump administration
Other Intervention Name(s)
analgesia pump 2
Intervention Description
Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.
Primary Outcome Measure Information:
Title
movement evoked pain (Numerical rating scale)
Description
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.
Time Frame
Each rehabilitation within 3 days after surgery
Title
pain at rest (Numerical rating scale)
Description
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.
Time Frame
Each rehabilitation within 3 days after surgery
Secondary Outcome Measure Information:
Title
satisfaction questionare of pain control
Description
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.
Time Frame
three days after surgery
Title
the time of first bowel movement
Description
Record the time of first bowel movement after surgery
Time Frame
three days after surgery
Title
total dose of analgesics
Description
record and calculate the total dose of analgesics
Time Frame
three days after surgery
Title
pain at night (Numerical rating scale)
Description
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.
Time Frame
three days after surgery
Title
adverse events during rehabilitation
Description
adverse events during rehabilitation, such as nausea, vomiting, headache, falls
Time Frame
three days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caijuan Xu, master
Phone
057187783887
Email
xucaijuan@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caijuan Xu, master
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caijuan Xu, master
Phone
057187783887
Email
zrhlb@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Yuping Zhang, master
Phone
057187783568
Email
zhangyuping@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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