UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051149 |
|---|---|
| Receipt number | R000058319 |
| Scientific Title | A study on the perioperative management after posterior spinal infusion - the effect of clinical pathway with around the clock analgesic medication. - |
| Date of disclosure of the study information | 2023/05/29 |
| Last modified on | 2025/11/24 11:36:28 |
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Basic information
Public title
A study on the perioperative management after posterior spinal infusion - the effect of clinical pathway with around the clock analgesic medication. -
Acronym
A study on the perioperative management after posterior spinal infusion - the effect of clinical pathway with around the clock analgesic medication. -
Scientific Title
A study on the perioperative management after posterior spinal infusion - the effect of clinical pathway with around the clock analgesic medication. -
Scientific Title:Acronym
A study on the perioperative management after posterior spinal infusion - the effect of clinical pathway with around the clock analgesic medication. -
Region
| Japan |
Condition
Condition
Posterior spinal infusion
Classification by specialty
| Orthopedics | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify perioperative management factors related to control analgesic medication due to posterior spinal infusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS point at rest in POD1
Key secondary outcomes
NRS point at rest from surgery end to POD3
The frequency of using analgesia.
The frequency of using antiemetic.
The day of getting out of bed.
The score of getting out of bed.
Amount of food eaten at first time meal.
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Scheduled posterior spinal infusion surgery (1 vertebral body).
And
(1) Subjects aged over 20.
(2) Sex ; male and female
(3) Subjects with American Society of Anesthesiologists physical status (ASA-PS) I or II
(4) Patients scheduled for surgery
(5) Patients in post group undergo patent support center.
(6) Patients in post group injected 4 times intravenous acetaminophen.
Key exclusion criteria
(1) Elevation of liver enzyme in postoperative period.
(2) Patients with alcoholic liver dysfunction.
(3) Patients in post group not undergo patent support center.
(4) Patients with unevaluable NRS and PONV.
(5) Patients with posterior spinal infusion with anterior infusion or multiple vertebral bodies.
(6) Patients with postoperative major complication.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Taniguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Patient Support Center
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
taniguchihideki@outlook.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Taniguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Patient Support Center
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
Homepage URL
taniguchihideki@outlook.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Hideki Taniguchi
Funding Source
Organization
Terumo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Tobu Hospital Institutional Review Board
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
Tel
045-576-3000
k_harita@tobu.saiseikai.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
済生会横浜市東部病院（神奈川県）
Saiseikai Yokohamashi Tobu Hosptital, Kanagawa
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
https://doi.org/10.1038/s41598-025-20499-4
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1038/s41598-025-20499-4
Number of participants that the trial has enrolled
78
Results
In elective spinal-fusion surgery, the introduction of ATC intravenous acetaminophen into the
clinical pathway improved postoperative analgesia.
Results date posted
| 2025 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
including patients who underwent elective spinal-fusion surgery, specifically PLIF or TLIF, with a fusion segment number of 1 (mono-segment).
Participant flow
PLIF and TLIF are spinal fusion procedures that are performed for degenerative spinal disease such as lumbar spinal stenosis. The inclusion criteria were as follows , age 20 years (no upper limit), any sex, American Society of Anesthesiologists physical status (ASAPS) , undergoing elective surgery, attendance in our patient support center before undergoing surgery, and receiving intravenous acetaminophen four times, including during the surgery, in the group receiving ATC acetaminophen administration (Postgroup).
Adverse events
none
Outcome measures
The primary endpoint was the numerical
rating scale (NRS) score at rest in the morning of the first postoperative day (POD). Secondary
endpoints were NRS scores on POD1-3, rescue analgesic use, postoperative nausea and vomiting
within 48 h, food intake, ambulation, and hospitalization length.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 09 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 30 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058319
