UMIN-CTR Clinical Trial

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
Email	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
Email	yoono@dent.meikai.ac.jp

Sponsor
Institute	Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053532