UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039157 |
|---|---|
| Receipt number | R000044660 |
| Scientific Title | The displacement of catheter in continuous peripheral nerve block |
| Date of disclosure of the study information | 2020/01/14 |
| Last modified on | 2025/02/10 11:11:04 |
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Basic information
Public title
The displacement of catheter in continuous peripheral nerve block
Acronym
The displacement of catheter in continuous peripheral nerve block
Scientific Title
The displacement of catheter in continuous peripheral nerve block
Scientific Title:Acronym
The displacement of catheter in continuous peripheral nerve block
Region
| Japan |
Condition
Condition
Patients undergoing continuous peripheral nerve block for postoperative analgesia
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the displacement of catheter in continuous peripheral nerve block before and after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance between catheter and nerve
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients ndergoing continuous peripheral nerve block for postoperative analgesia
Key exclusion criteria
Patients without consent, who are allergic to the drugs used, with abnormal coagulation or thrombocytopenia, with inadequate decision-making ability, with cognitive decline
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Hara |
Organization
Kumamoto university hospital
Division name
Department of anesthesia
Zip code
860-8556
Address
1-1-1 Honjo,Tyuo-ku,Kumamoto City,Kumamoto
TEL
096-344-2111
marie.v.dm107@gmail.com
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Hara |
Organization
Kumamoto university hospital
Division name
Department of anesthesia
Zip code
860-8556
Address
1-1-1 Honjo,Tyuo-ku,Kumamoto City,Kumamoto
TEL
096-344-2111
Homepage URL
marie.v.dm107@gmail.com
Sponsor or person
Institute
Kumamoto university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto university hospital IRB
Address
1-1-1 Honjo,Tyuo-ku,Kumamoto City,Kumamoto
Tel
096-344-2111
marie.v.dm107@gmail.com
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
| 2020 | Year | 01 | Month | 14 | 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
33
Results
The median distance from the distal side pore of the catheter to the midpoint between the C5 and C6 root was 5.0 [4.1, 6.5] mm at the time of catheter placement, 2.8 [0.1, 5.0] mm immediately after surgery and 0.0 [-4.3, 2.2] mm at the time of catheter removal the day after surgery. While the position of the catheter at the insertion site has not changed in all patients, the distal side pore of the pigtail catheter was moved backward by the first postoperative day in 20 of 22 patients (90.6 %).
Results date posted
| 2024 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-tree patients undergoing arthroscopic rotator cuff repair surgery were enrolled in this study. Eleven patients were excluded from the analysis. Finally, 22 patients were analysed in our study.
The patients' characteristics are given below.
Age 65 [58, 70]
BMI (kg/m2) 25.8 [23.2, 26.2]
Sex (male), n (%) 18 (81.8)
Values are presented as median [interquartile range]
Participant flow
The patients underwent arthroscopic rotator cuff repair surgery at Kumamoto University Hospital were enrolled in this study from April 1st 2020 were enrolled. The exclusion criteria were refusal to participate, contraindications to peripheral nerve block (e.g., allergy to local anesthetics or coagulopathy), severe diabetes, and an inability to assess the VAS pain score because of dementia. We obtained written informed consent from all patients.
Adverse events
none
Outcome measures
distance from the distal side pore of the catheter to the midpoint between the C5 and C6 root
VAS score measured on postoperative day 1 at the time of catheter removal
frequency of using rescue analgesia
block-related complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The distance between the catheter and the nerve is measured after the peripheral nerve block, immediately after the operation, and when the catheter is removed.The analgesic effect, complications, and factors of the catheter displacement are also examined.
Management information
Registered date
| 2020 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044660
