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

NCT03823846 | Unknown DMC

• 1 other identifier: 2017-084
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To establish doctor-nurse-patient cooperative analgesic linkage program.
2. 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.

Conditions

Pain, Postoperative; Anaplasia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Each rehabilitation within 3 days after surgery

Secondary Outcomes (5)

• satisfaction questionare of pain control

  three days after surgery

• the time of first bowel movement

  three days after surgery

• total dose of analgesics

  three days after surgery

• pain at night (Numerical rating scale)

  three days after surgery

• adverse events during rehabilitation

  three days after surgery

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

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.

Drug: Routine Dezocine injection; Drug: Routine Dynastat or Flurbiprofen Axetil jinjection; Other: postoperative rehabilitation; Drug: normal analgesia pump administration

Interventions

Routine Dezocine injection DRUG

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

Also known as: Dezocine 1

control group

Adjusted Dezocine injection DRUG

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

Also known as: Dezocine 2

Experimental Group

Routine Dynastat or Flurbiprofen Axetil jinjection DRUG

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

Also known as: Dynastat or Flurbiprofen Axetil 1

control group

Adjusted Dynastat or Flurbiprofen Axetil jinjection DRUG

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

Also known as: Dynastat or Flurbiprofen Axetil 2

Experimental Group

postoperative rehabilitation OTHER

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

Also known as: rehabilitation

Experimental Group; control group

normal analgesia pump administration DRUG

Dose of analgesia pump was added if needed.

Also known as: analgesia pump 1

control group

adjusted analgesia pump administration DRUG

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

Also known as: analgesia pump 2

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Anaplasia; Agnosia; Pancreatic Diseases

Interventions

parecoxib; Rehabilitation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplastic Processes; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Caijuan Xu, master

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caijuan Xu, master

CONTACT

057187783887; xucaijuan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 31, 2019
• Study Start: November 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)