UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063106 |
|---|---|
| Receipt number | R000072200 |
| Scientific Title | Efficacy of Intraoperative Nitrous Oxide for Chronic Postoperative Pain and the Role of Genetic Polymorphisms in Patients With Cervical Spinal Cord Injury: An Exploratory Single-Arm Prospective Interventional Study |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 23:24:23 |
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Basic information
Public title
Efficacy of Intraoperative Nitrous Oxide for Chronic Postoperative Pain and the Role of Genetic Polymorphisms in Patients With Cervical Spinal Cord Injury: An Exploratory Single-Arm Prospective Interventional Study
Acronym
Efficacy of Intraoperative Nitrous Oxide for Chronic Postoperative Pain and the Role of Genetic Polymorphisms in Patients With Cervical Spinal Cord Injury
Scientific Title
Efficacy of Intraoperative Nitrous Oxide for Chronic Postoperative Pain and the Role of Genetic Polymorphisms in Patients With Cervical Spinal Cord Injury: An Exploratory Single-Arm Prospective Interventional Study
Scientific Title:Acronym
INOPPs2 study
Region
| Japan |
Condition
Condition
Traumatic cervical spinal cord injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the association between genetic polymorphisms and chronic-phase neuropathic pain in patients receiving intraoperative Nitrous oxides.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
NRS at 6 months
Key secondary outcomes
NRS at rest and during movement (postoperative days 1-2, 6 months, 1 year)
NRS for numbness and Neuropathic Pain Symptom Inventory (NPSI) (6 months, 1 year postoperatively);
genetic polymorphism types (C677T/A1298C)
assessment of activities of daily living (6 months, 1 year postoperatively)
patient satisfaction (6 months, 1 year postoperatively)
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intraoperative nitrous oxide inhalation
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
Patients aged 20 or older with cervical spinal cord injury (classified as ASIA C or D) who were transported to Saitama Medical Center and determined to require surgery.
Individuals who received a full explanation regarding participation in this study, demonstrated sufficient understanding, and provided written informed consent based on their own free will.
Key exclusion criteria
1) Pneumothorax or head trauma
2) Trauma to the limbs (fractures or nerve injuries)
3) Non-Japanese speakers
4) Impaired consciousness (making assessment difficult)
5) Patients already enrolled in another clinical trial
6) Comorbid psychiatric disorders (e.g., suicidal ideation)
7) Comorbid limb trauma
8) History of blood disorders
9) Patients taking NMDA receptor antagonists
10) Individuals who did not provide written informed consent
11) Individuals who withdrew consent
12) Any other individuals deemed unsuitable by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medial Center
Division name
Anesthesiology
Zip code
3500844
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
0492283654
tkatoh@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medial Center
Division name
Anesthesiology
Zip code
3500844
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
0492283654
Homepage URL
tkatoh@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Saitama Medical University General Medical Center
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
Tel
049-228-3902
smcrinri@saitama-med.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
| 2026 | Year | 09 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072200
