UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034071 |
|---|---|
| Receipt number | R000038823 |
| Scientific Title | Effect of peripheral nerve block on post-operative delirium and post-operative cognitive dysfunction following total hip arthroplasty in elderly patients. |
| Date of disclosure of the study information | 2018/09/09 |
| Last modified on | 2020/05/20 13:16:19 |
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Basic information
Public title
Effect of peripheral nerve block on post-operative delirium and post-operative cognitive dysfunction following total hip arthroplasty in elderly patients.
Acronym
Effect of PNB on POD and POCD following total hip arthroplasty in elderly patients.
Scientific Title
Effect of peripheral nerve block on post-operative delirium and post-operative cognitive dysfunction following total hip arthroplasty in elderly patients.
Scientific Title:Acronym
Effect of PNB on POD and POCD following total hip arthroplasty in elderly patients.
Region
| Japan |
Condition
Condition
Patients aged over 60 who undergo total hip arthroplasty under general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effectiveness of fascia iliaca block for prevention of postoperative delirium and post-operative cognitive dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of post-operative delirium and post-operative cognitive dysfunction.
Key secondary outcomes
intra-operative opioid dose
intraoperative Patient Status Index (PSI) and Spectral Edge Freguency (SEF), Surpression Rate (SR), Local Oximetry (rSO 2)
postoperative pain level on Day1 and Day 2
Frequency of use of PCA
use of auxiliary analgesics
occurrence of side effects by opioid (nausea / vomiting, dizziness, respiratory depression etc)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Fascia iliaca block
Interventions/Control_2
No therapy
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo total hip arthroplasty under general anesthesia.
Key exclusion criteria
1) Patients who are impaired in perception and difficult to undergo cognitive function tests.
2) Patients who can not complete the cognitive function tests.
3) Patients who have neurological disorders.
4) Patients who have mental illness.
5) Patients who have coagulopathy.
6) Patients who have history of cardiac surgery (open heart surgery) and brain surgery.
7) Patients who have alcoholism and drug addiction.
8) Patients who are allergic to local anesthetic.
9) Patients who judged inappropriate by research doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Hosokawa |
Organization
Showa university
Division name
Department of Anesthesiology
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
maiko-hskw@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Hosokawa |
Organization
Showa university
Division name
Department of Anesthesiology
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
Homepage URL
maiko-hskw@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Showa university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 09 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | 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
Management information
Registered date
| 2018 | Year | 09 | Month | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038823
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
