UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050260 |
|---|---|
| Receipt number | R000057226 |
| Scientific Title | A Retrospective Observational Study of Operating Room Efficiency Operation with Pre-insertion of Brachial Plexus Block Catheter in Shoulder Arthroplasty |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2024/03/28 14:13:49 |
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Basic information
Public title
A Retrospective Observational Study of Operating Room Efficiency Operation with Pre-insertion of Brachial Plexus Block Catheter in Shoulder Arthroplasty
Acronym
A Retrospective Observational Study of Operating Room Efficiency Operation with Pre-insertion of Brachial Plexus Block Catheter in Shoulder Arthroplasty
Scientific Title
A Retrospective Observational Study of Operating Room Efficiency Operation with Pre-insertion of Brachial Plexus Block Catheter in Shoulder Arthroplasty
Scientific Title:Acronym
A Retrospective Observational Study of Operating Room Efficiency Operation with Pre-insertion of Brachial Plexus Block Catheter in Shoulder Arthroplasty
Region
| Japan |
Condition
Condition
rotator cuff tear
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to reduce operating room utilization, operating room turnover time, and overtime surgeries, our hospital has begun preinsertion of brachial plexus block catheters for postoperative analgesia in shoulder arthroplasty. In this study, we retrospectively examined whether pre-insertion of catheters in patients undergoing arthroscopic rotator cuff repair, the most frequently performed shoulder joint surgery, contributed to operating room efficiency without disadvantage to the patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is to compare the time from patient admission to the start of general anesthesia between the catheter pre-insertion group and the catheter pre-insertion group as a control group to determine whether catheter pre-insertion contributes to operating room efficiency.
Key secondary outcomes
As a secondary outcome, we would like to examine whether catheter preinsertion is disadvantageous to patients by comparing the use of remifentanil, an analgesic used during surgery, the postoperative resting shoulder pain numerical rating scale (NRS), and the rate of catheter reinsertion. The results of this study will be presented at the end of the study. In addition, we would like to compare the time of leaving the operating room before and after pre-catheter insertion in shoulder joint surgery patients, and to examine whether the overtime hours of medical staff could be reduced.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent arthroscopic shoulder rotator cuff repair between January 2021 and December 2022 and who received a continuous brachial plexus block for postoperative analgesia will be eligible.
Key exclusion criteria
An open letter will be prepared and patients will be excluded from the study if they are informed that they do not wish to be included in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadanao |
| Middle name | |
| Last name | Hiroki |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-15, showa-machi, Maebashi, Gunma, Japan.
TEL
027-220-8454
t-hiroki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadanao |
| Middle name | |
| Last name | Hiroki |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan.
TEL
0272208454
Homepage URL
t-hiroki@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan.
Tel
027-220-8763
hitotaisho-ciru@ml.gunma-u.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
| 2023 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
148
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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study and will be implemented between February 9 and March 31, 2023 for data collection and analysis.
Management information
Registered date
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057226
