UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of image-guided nerve block in pain therapy.
Acronym	clinical evaluation of nerve block
Scientific Title	Clinical evaluation of image-guided nerve block in pain therapy.
Scientific Title:Acronym	clinical evaluation of nerve block
Region	Japan

Condition
Condition	refractory pain, chronic pain, cancer pain
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate of image-guided nerve block in pain therapy and palliative care
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	imaging of ultrasound or CT, peripheral circulation, skin temperature, nerve block area, duration of the effect, pain score, satisfaction of QOL
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	nerve block for pain therapy, under imaging guidance of ultrasound or CT, times of intervention: 1 ~ several times, one nerve block in a day,
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	adult patients need nerve block therapy nothing of contraindication for nerve block
Key exclusion criteria	under adult aged patients contraindication for nerve block
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yoji Middle name Last name Yoji
Organization	Shimane University Faculty of Medicine
Division name	Department of Anesthesiology
Zip code	693-8501
Address	89-1, Enya-cho, Izumi
TEL	0853-20-2295
Email	ysaito@shimane-u.med.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Nakatani
Organization	Shimane University Faculty of Medicine
Division name	Department of Palliative Care
Zip code	693-8501
Address	89-1, Enya-cho, Izumi
TEL	0853-20-2237
Homepage URL
Email	tnktn@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization	Shimane University Faculty of Medicine
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	clinical research center
Address	enya-cho, Izumo
Tel	0853-20-2111
Email	kenkyu@med.shimane-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	2017 Year 04 Month 10 Day

Related information
URL releasing protocol	https://www.dovepress.com/journal-of-pain-research-journal
Publication of results	Unpublished

Result
URL related to results and publications	https://www.dovepress.com/journal-of-pain-research-journal
Number of participants that the trial has enrolled	9
Results	Evation in temperature: by over 1 (sympathetic block, n = 62) and by less than 1 (non-sympathetic block, n = 27). Finger blood flow decreased significantly just after a change in posture after SGB in both groups. In the sympathetic block group, the ratio of finger blood flow in the long sitting position / supine position with a change in posture significantly increased after SGB compared with before SGB (before SGB: range 0.09-0.94, median 0.53, after SGB: range 0.33-1.2, median 0.89, p < 0.0001).
Results date posted	2021 Year 04 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication.
Participant flow	Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication.
Adverse events	none
Outcome measures	1. Horner sign. After SGB, we checked for the presence of myosis, ptosis and enophthalmos. This was assessed to identify successful block of the cervical sympathetic trunk. 2. Presence of brachial nerve block, to exclude sympathetic block in the upper limb due to inadvertent brachial plexus block. In patients in whom it did occur, a significant increase in blood flow to the fingers of the blocked hand was observed throughout the period of brachial plexus anesthesia.4 We checked the presence of brachial nerve block or not. 3. Skin temperature of the thumb on the blocked side by thermography before SGB and 20 min after SGB. An indicator of sympathetic block in the upper limb is elevated skin temperature of over 1 relative to before SGB. 4. Blood flow in the ball of the thumb on the SGB side. This was measured using a laser blood flow meter (Laser Doppler ALF 21D, ADMEDIC Co. Ltd., Japan) in the supine position and immediately after changing to the long sitting position (the lowest finger blood flow), before SGB and 20 min after SGB.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 05 Day
Date of IRB	2013 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 04 Month 10 Day
Last follow-up date	2018 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	2017 Year 04 Month 05 Day
Last modified on	2021 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030831