UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055777 |
|---|---|
| Receipt number | R000063737 |
| Scientific Title | Development and Evaluation of eAPS: A Postoperative Pain Management Service Utilizing an In-Hospital Telemedicine System |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2025/04/14 17:03:59 |
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Basic information
Public title
A Study on eAPS: A Postoperative Pain Management Service Utilizing an In-Hospital Telemedicine System
Acronym
A Study on eAPS: A Telemedicine Postoperative Pain Service
Scientific Title
Development and Evaluation of eAPS: A Postoperative Pain Management Service Utilizing an In-Hospital Telemedicine System
Scientific Title:Acronym
A Study on eAPS: A Telemedicine Postoperative Pain Service
Region
| Japan |
Condition
Condition
Total knee replacement patient
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By changing the flow of information and treatment from patient to nurse, doctor, nurse, and patient to patient to doctor, patient, or patient to doctor, nurse, and patient, we can improve postoperative pain management. The aim is to test the hypothesis that "response will be more timely, the time from chief complaint to treatment can be shortened, pain control can be improved, and patient satisfaction can be increased."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain control, complications from pain treatments, hospital stays, and patient satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The tablet will be used after the surgery is completed and you return to the ward. Always keep a tablet by your bedside and open it when necessary to input data. The self-assessment screen entered by the patient is received on both the ward nurse's mobile terminal and the APS team's mobile terminal. The APS doctor who receives the patient report sends the APS response to the patient and ward nurses from a mobile device. For example, in the case of poor pain control with an NRS (pain score) of 5 or higher, or new onset of motor/sensory impairment, the APS team physician will immediately advise the patient that the patient is ``coming soon'' and immediately examine the patient. conduct. For other non-urgent cases, instruct the nurse to deal with the patient. Tablets will be discontinued once IVPCA is no longer needed during APS rounds.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for knee arthroplasty using IVPCA (fentanyl) postoperatively
Key exclusion criteria
Patients who are using opioids before surgery or who cannot use tablets
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Uezono |
Organization
The Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
1058461
Address
3-25-8 Nishishimbashi Minato-ku Tokyo
TEL
0334331111
uezono@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
1058461
Address
3-25-8 Nishishimbashi Minato-ku Tokyo
TEL
0334331111
Homepage URL
ichirok@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8 Nishishimbashi Minato-ku Tokyo
Tel
0334331111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063737
