UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048817 |
|---|---|
| Receipt number | R000055559 |
| Scientific Title | Effectiveness of Intraoperative Nitrous Oxide for Postoperative Pain in Lumbar Spinal Fusion Surgery: A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2022/09/02 |
| Last modified on | 2022/09/28 22:45:17 |
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Basic information
Public title
Effectiveness of Intraoperative Nitrous Oxide for Postoperative Pain in Lumbar Spinal Fusion Surgery: A Randomized Controlled Trial.
Acronym
Efficacy of N2O in PLIF for postoperative pain.
Scientific Title
Effectiveness of Intraoperative Nitrous Oxide for Postoperative Pain in Lumbar Spinal Fusion Surgery: A Randomized Controlled Trial.
Scientific Title:Acronym
Efficacy of N2O in PLIF for postoperative pain.
Region
| Japan |
Condition
Condition
Postoperative pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intraoperative N2O use to study low back pain and lower limb pain after lumbar spinal fusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
low back pain and lower limb pain intensity (Numerical Rating Scale (NRS): 0-10) up to 48 hours postoperatively.
Key secondary outcomes
(1) Postoperative numbness in the lower limb (numbness score: 0-3)
(2) Dose of fentanyl by iv-PCA
(3) Number of times of administration of adjuvant analgesics
(4) Number of points of nausea and vomiting
(5) Relationship between time to surgery and pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention is performed during general anesthesia; in the N2O group, general anesthesia is maintained with 60% N2O and 40% FIO2 after tracheal intubation. N2O administration will be terminated immediately after the end of surgery.
Interventions/Control_2
Intervention is performed during general anesthesia. In the air group, general anesthesia is maintained at 40% FIO2 by mixing air and oxygen after tracheal intubation. Air administration will be terminated immediately after the end of surgery.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with ASA (American Society of Anesthesiologist) classification I-II who will undergo lumbar spinal fusion between September 2022 and April 2024 at Keiyu Orthopaedic Hospital will be included.
Key exclusion criteria
Due to trauma (fracture, nerve damage), not speaking Japanese, impaired consciousness (if difficult to assess). Complications of psychiatric disorders, history of blood disorders.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Fujita |
Organization
Keiyu Orthopedic Hospital
Division name
Director of a hospital
Zip code
374-0013
Address
2267-1 Akauda-cho, Tatebayashi, Gunma, Japan.
TEL
0276-49-9000
nao.fjt@gmail.com
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Fujita |
Organization
Keiyu Orthopedic Hospital
Division name
Director of a hospital
Zip code
374-0013
Address
2267-1 Akauda-cho, Tatebayashi, Gunma, Japan.
TEL
0276-49-9000
Homepage URL
nao.fjt@gmail.com
Sponsor or person
Institute
Keiyu Orthopedic Hospital
Institute
Department
Personal name
Funding Source
Organization
Keiyu Orthopedic Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of Keiyu Orthopedic Hospital
Address
2267-1 Akauda-cho, Tatebayashi, Gunma, Japan.
Tel
0276-49-9000
ethical_commitee@ku-kai.or.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 | 09 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055559
| Research Plan | |
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| Registered date | File name |
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