Pain, PostoperativeNCT03823846
the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain
A study testing Routine Dezocine injection, Adjusted Dezocine injection and Routine Dynastat or Flurbiprofen Axetil jinjection in people with Pain, Postoperative and Anaplasia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anaplasia
- What is being tested?
- Routine Dezocine injection, Adjusted Dezocine injection and Routine Dynastat or Flurbiprofen Axetil jinjection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Caijuan Xu, master, 057187783887, zrhlb@zju.edu.cn
Yuping Zhang, master, 057187783568, zhangyuping@zju.edu.cn
About this study
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
- 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.
Read the 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.
- Conditions
- Pain, Postoperative, Anaplasia
- Being tested
- Routine Dezocine injection, Adjusted Dezocine injection, Routine Dynastat or Flurbiprofen Axetil jinjection, Adjusted Dynastat or Flurbiprofen Axetil jinjection, postoperative rehabilitation
- Keywords
- movement evoked pain, analgesia, general surgery, hepatobiliary and pancreatic disease
- Medical subject headings
- Pain, Postoperative, Anaplasia, Agnosia, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Dezocine injectionDrug
Also called Dezocine 1
Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
Adjusted Dezocine injectionDrug
Also called Dezocine 2
Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.
Routine Dynastat or Flurbiprofen Axetil jinjectionDrug
Also called Dynastat or Flurbiprofen Axetil 1
Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.
Adjusted Dynastat or Flurbiprofen Axetil jinjectionDrug
Also called Dynastat or Flurbiprofen Axetil 2
Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.
postoperative rehabilitationOther
Also called rehabilitation
Rehabilitation was conducted at 8:00am and 2:00pm.
normal analgesia pump administrationDrug
Also called analgesia pump 1
Dose of analgesia pump was added if needed.
adjusted analgesia pump administrationDrug
Also called analgesia pump 2
Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program. Receives: Drug: Adjusted Dezocine injection; Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection; Other: postoperative rehabilitation; Drug: adjusted analgesia pump administration |
| control group | Active comparator | Patients in the control group were received routine analgesic and functional rehabilitation. Receives: Drug: Routine Dezocine injection; Drug: Routine Dynastat or Flurbiprofen Axetil jinjection; Other: postoperative rehabilitation; Drug: normal analgesia pump administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each rehabilitation within 3 days after surgery
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.
Measured: Each rehabilitation within 3 days after surgery
Secondary outcomes (5)
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.
Measured: three days after surgery
the time of first bowel movement
Record the time of first bowel movement after surgery
Measured: three days after surgery
total dose of analgesics
record and calculate the total dose of analgesics
Measured: three days after surgery
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.
Measured: three days after surgery
adverse events during rehabilitation
adverse events during rehabilitation, such as nausea, vomiting, headache, falls
Measured: three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Nov 2017
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caijuan Xu, master, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823846
- Sponsor's protocol ID
- 2017-084
- Status last verified
- Apr 2019
- First submitted
- 23 Jan 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03823846
- Acronym / sponsor ID
- 2017-084
- Conditions
- Pain, Postoperative, Anaplasia
- Keywords
- movement evoked pain, analgesia, general surgery, hepatobiliary and pancreatic disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Adjusted Dezocine injection, Drug: Adjusted Dynastat or Flurbiprofen Axetil jinjection, Other: postoperative rehabilitation, Drug: adjusted analgesia pump administrationPatients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program. |
| control group | Active comparator | Drug: Routine Dezocine injection, Drug: Routine Dynastat or Flurbiprofen Axetil jinjection, Other: postoperative rehabilitation, Drug: normal analgesia pump administrationPatients in the control group were received routine analgesic and functional rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Dezocine injectionAlso: Dezocine 1Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm. | Drug | control group |
| Adjusted Dezocine injectionAlso: Dezocine 2Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm. | Drug | Experimental Group |
| Routine Dynastat or Flurbiprofen Axetil jinjectionAlso: Dynastat or Flurbiprofen Axetil 1Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm. | Drug | control group |
| Adjusted Dynastat or Flurbiprofen Axetil jinjectionAlso: Dynastat or Flurbiprofen Axetil 2Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm. | Drug | Experimental Group |
| postoperative rehabilitationAlso: rehabilitationRehabilitation was conducted at 8:00am and 2:00pm. | Other | Experimental Group, control group |
| normal analgesia pump administrationAlso: analgesia pump 1Dose of analgesia pump was added if needed. | Drug | control group |
| adjusted analgesia pump administrationAlso: analgesia pump 2Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation. | Drug | Experimental Group |
Primary outcome
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.
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.
5 secondary outcomes
satisfaction questionare of pain control
Time frame: three days after surgery
the time of first bowel movement
Time frame: three days after surgery
total dose of analgesics
Time frame: three days after surgery
pain at night (Numerical rating scale)
Time frame: three days after surgery
adverse events during rehabilitation
Time frame: three days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caijuan Xu, master principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Dezocine injection, Adjusted Dezocine injection and Routine Dynastat or Flurbiprofen Axetil jinjection in people with Pain, Postoperative and Anaplasia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caijuan Xu, master (057187783887, xucaijuan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
movement evoked pain (Numerical rating scale) (time frame: Each rehabilitation within 3 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.