Clinical trial NCT03823846: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Anaplasia
Keywords: movement evoked pain
analgesia
general surgery
hepatobiliary and pancreatic disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: movement evoked pain (Numerical rating scale)
timeFrame: Each rehabilitation within 3 days after surgery
measure: pain at rest (Numerical rating scale)
timeFrame: Each rehabilitation within 3 days after surgery
Secondary outcomes:
measure: satisfaction questionare of pain control
timeFrame: three days after surgery
measure: the time of first bowel movement
timeFrame: three days after surgery
measure: total dose of analgesics
timeFrame: three days after surgery
measure: pain at night (Numerical rating scale)
timeFrame: three days after surgery
measure: adverse events during rehabilitation
timeFrame: three days after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Caijuan Xu, master
role: PRINCIPAL_INVESTIGATOR
References: