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

NCT ID: NCT03823846

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Anaplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

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

Group Type EXPERIMENTAL

Adjusted Dezocine injection

Intervention Type DRUG

Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.

Adjusted Dynastat or Flurbiprofen Axetil jinjection

Intervention Type DRUG

Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.

postoperative rehabilitation

Intervention Type OTHER

Rehabilitation was conducted at 8:00am and 2:00pm.

adjusted analgesia pump administration

Intervention Type DRUG

Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.

control group

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

Group Type ACTIVE_COMPARATOR

Routine Dezocine injection

Intervention Type DRUG

Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.

Routine Dynastat or Flurbiprofen Axetil jinjection

Intervention Type DRUG

Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.

postoperative rehabilitation

Intervention Type OTHER

Rehabilitation was conducted at 8:00am and 2:00pm.

normal analgesia pump administration

Intervention Type DRUG

Dose of analgesia pump was added if needed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Routine Dezocine injection

Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.

Intervention Type DRUG

Adjusted Dezocine injection

Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.

Intervention Type DRUG

Routine Dynastat or Flurbiprofen Axetil jinjection

Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.

Intervention Type 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.

Intervention Type DRUG

postoperative rehabilitation

Rehabilitation was conducted at 8:00am and 2:00pm.

Intervention Type OTHER

normal analgesia pump administration

Dose of analgesia pump was added if needed.

Intervention Type DRUG

adjusted analgesia pump administration

Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dezocine 1 Dezocine 2 Dynastat or Flurbiprofen Axetil 1 Dynastat or Flurbiprofen Axetil 2 rehabilitation analgesia pump 1 analgesia pump 2

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caijuan Xu, master

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Caijuan Xu, master

Role: CONTACT

057187783887

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Caijuan Xu, master

Role: primary

057187783887

Yuping Zhang, master

Role: backup

057187783568

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-084

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multimodal and Unimodal Analgesia in Cholecystectomy
NCT05547659 COMPLETED PHASE1/PHASE2