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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03823846
Enrollment
80
Registered
2019-01-31
Start date
2017-11-01
Completion date
2020-10-01
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaplasia, Pain, Postoperative

Keywords

movement evoked pain, analgesia, general surgery, hepatobiliary and pancreatic disease

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.

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.

Interventions

DRUGRoutine Dezocine injection

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

DRUGAdjusted Dezocine injection

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

DRUGRoutine Dynastat or Flurbiprofen Axetil jinjection

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

DRUGAdjusted Dynastat or Flurbiprofen Axetil jinjection

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

OTHERpostoperative rehabilitation

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

DRUGnormal analgesia pump administration

Dose of analgesia pump was added if needed.

DRUGadjusted analgesia pump administration

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
movement evoked pain (Numerical rating scale)Each rehabilitation within 3 days after surgeryAssess 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)Each rehabilitation within 3 days after surgeryAssess 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

MeasureTime frameDescription
total dose of analgesicsthree days after surgeryrecord and calculate the total dose of analgesics
satisfaction questionare of pain controlthree days after surgeryPatients 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.
adverse events during rehabilitationthree days after surgeryadverse events during rehabilitation, such as nausea, vomiting, headache, falls
pain at night (Numerical rating scale)three days after surgeryAsess 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.
the time of first bowel movementthree days after surgeryRecord the time of first bowel movement after surgery

Countries

China

Contacts

Primary ContactCaijuan Xu, master
xucaijuan@zju.edu.cn057187783887

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026