UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026873 |
|---|---|
| Receipt number | R000030831 |
| Scientific Title | Clinical evaluation of image-guided nerve block in pain therapy. |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2021/04/08 13:40:09 |
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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
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
tnktn@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030831
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