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

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ClinicalTrials.gov Identifier: NCT03823846
Recruitment Status : Unknown
Verified April 2019 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : January 31, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Anaplasia Drug: Routine Dezocine injection Drug: Adjusted Dezocine injection Drug: Routine Dynastat or Flurbiprofen Axetil jinjection Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection Other: postoperative rehabilitation Drug: normal analgesia pump administration Drug: adjusted analgesia pump administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dynastat or Flurbiprofen Axetil 2

Other: postoperative rehabilitation
Rehabilitation was conducted at 8:00am and 2:00pm.
Other Name: 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 Name: analgesia pump 2

Active Comparator: control group
Patients in the control group were received routine analgesic and functional rehabilitation.
Drug: Routine Dezocine injection
Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
Other Name: 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 Name: Dynastat or Flurbiprofen Axetil 1

Other: postoperative rehabilitation
Rehabilitation was conducted at 8:00am and 2:00pm.
Other Name: rehabilitation

Drug: normal analgesia pump administration
Dose of analgesia pump was added if needed.
Other Name: analgesia pump 1




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. the time of first bowel movement [ Time Frame: three days after surgery ]
    Record the time of first bowel movement after surgery

  3. total dose of analgesics [ Time Frame: three days after surgery ]
    record and calculate the total dose of analgesics

  4. 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.

  5. adverse events during rehabilitation [ Time Frame: three days after surgery ]
    adverse events during rehabilitation, such as nausea, vomiting, headache, falls



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823846


Contacts
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Contact: Caijuan Xu, master 057187783887 xucaijuan@zju.edu.cn

Locations
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China, Zhejiang
Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Caijuan Xu, master    057187783887    zrhlb@zju.edu.cn   
Contact: Yuping Zhang, master    057187783568    zhangyuping@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Caijuan Xu, master Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03823846    
Other Study ID Numbers: 2017-084
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
movement evoked pain
analgesia
general surgery
hepatobiliary and pancreatic disease
Additional relevant MeSH terms:
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Anaplasia
Pancreatic Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Digestive System Diseases
Neoplastic Processes
Neoplasms
Flurbiprofen
Flurbiprofen axetil
Parecoxib
Dezocine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Analgesics, Opioid
Narcotics
Central Nervous System Depressants