UMIN-CTR Clinical Trial

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
Email	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
Email	maiko-hskw@med.showa-u.ac.jp

Sponsor
Institute	Showa university
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038823