UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046957 |
|---|---|
| Receipt number | R000053532 |
| Scientific Title | The elucidation for the risk factor of acute and chronic post-operative pain |
| Date of disclosure of the study information | 2022/02/20 |
| Last modified on | 2022/02/20 23:35:24 |
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Basic information
Public title
The elucidation for the risk factor of acute and chronic post-operative pain
Acronym
The elucidation for the risk factor of acute and chronic post-operative pain
Scientific Title
The elucidation for the risk factor of acute and chronic post-operative pain
Scientific Title:Acronym
The elucidation for the risk factor of acute and chronic post-operative pain
Region
| Japan |
Condition
Condition
dental surgery
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The ellucidation for the risk factor of acute and chronic post-operative pain
Basic objectives2
Others
Basic objectives -Others
analyze of postoperative pain, patient characteristics and CPM, TPI, TS, and OA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between Conditioned Pain Modulation (CPM), Thermal Pain Illusion (TPI), Temporal Summation (TS), Offset Analgesia (OA) and analgesic consumption, postoperative pain, and patient background (for example, psychology test including SDS, STAI, PCS etc.)
(CPM effect: assessed by Quantitative Sensory Testing (QST) such as Pressure Pain threshold measured by pressure algometer or threshold measured by von Frey filament as subjective evaluation and objective evaluation by Visual Analogue Scale (VAS) etc. The CPM effect is evaluated during and after conditioning stimulation. CPM effect is defined as ratio of pain threshold of TS during CS to pain threshold before application of CS (baseline).
TPI: paradoxical sensation caused by cold heat pulse stimulation
TS: triggered by repeated thermal stimulation and assessed by VAS.
OA: triggered by thermal stimulation and assessed by VAS.)
Key secondary outcomes
The effect of stress on Catecholamine concentrations in plasma and urine and sweat.
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
scheduled dental surgery patient and healthy volunteers after informed consent is obtained, over 16 years old and under 90 years old
Key exclusion criteria
the inability to give informed consent, under 16 years old, over 91 years old
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Oono |
Organization
Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology
Zip code
350-0283
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
0492792738
yoono@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Oono |
Organization
Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Division name
Division of Dental Anesthesiology
Zip code
350-0283
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
049-279-2738
Homepage URL
yoono@dent.meikai.ac.jp
Sponsor or person
Institute
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meikai University
Address
1-1, Keyakidai, Sakado-shi, Saitama
Tel
049-279-2712
kenkyu@dent.meikai.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
| 2022 | Year | 02 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tonic conditioning stimulus (CS) is applied to the forearm by quantitative thermal stimulator device (QTSD) with a pain intensity of 70 on VAS (0-100) for about 5 minutes. For CPM evaluation, pressure pain threshold (PPT) is measured at contralateral forearm before, during, and after CS.
Management information
Registered date
| 2022 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053532
