UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analgesic effect evaluation of nerve block during general anesthesia using pupillometry ~ Pilot study ~
Title of the study (Brief title)	Analgesic effect evaluation of nerve block during general anesthesia using pupillometry ~ Pilot study ~
Region	Japan

Condition
Condition	knee osteoarthritis
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pupillometry to detect pain response during general anesthesia for evaluation of analgesic effect of nerve block has been reported. In this study, we analyze the change in pupil diameter after femoral nerve block, and investigate and analyze useful index for analgesic effect determination.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	time of determination of analgesic effect of nerve block by pupillometry
Key secondary outcomes	change in pupil diameter, reaction latency, reaction rate

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients aged 20 years or older who undergo femoral nerve block during general anesthesia
Key exclusion criteria	Patients with pupillary dysfunction Patients with ophthalmic nerve paralysis Patients using opioids before surgery Patients using drugs affect pupil diameter change(anticholinergics, dopamine D2 receptor antagonists) Patients who can not use propofol
Target sample size	10

Research contact person
Name of lead principal investigator	Miho Wakabayashi
Organization	Wakayama medical university
Division name	department of anesthesiology
Address	811-1 Kimiidera, Wakayama-city, Wakayama, Japan
TEL	073-441-0611
Email	mmasaki@wakayama-med.ac.jp

Public contact
Name of contact person	Miho Wakabayashi
Organization	Wakayama medical university
Division name	department of anesthesiology
Address	811-1 Kimiidera, Wakayama-city, Wakayama, Japan
TEL	073-441-0611
Homepage URL
Email	mmasaki@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university, department of anesthesiology
Institute
Department

Funding Source
Organization	Wakayama medical university, department of anesthesiology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 05 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 05 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	After administration of propofol, ultrasound-guided femoral nerve block is performed and electrical stimulation is performed to an anterior surface of the knee. We measure pupil diameter before and after stimulation, before the administration of the local anesthetic solution, 1 minute, 3 minutes, 5 minutes, 10 minutes, 15 minutes after the administration of the local anesthetic solution. Also, as a control, electrical stimulation is similarly applied to the anterior surface of the knee on the contralateral side, and pupil diameter are measured.

Management information
Registered date	2018 Year 12 Month 05 Day
Last modified on	2018 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040053