UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052012 |
|---|---|
| Receipt number | R000059287 |
| Scientific Title | Ultrasound-guided inter-semispinal plane block versus surgical wound infiltration in perioperative analgesia for cervical spine surgery: A Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/03/06 10:11:01 |
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Basic information
Public title
Comparative study of the effectiveness of ultrasound-guided inter-semispinal plane block versus wound infiltrationin cervical spine surgery
Acronym
Postoperative analgesic effect of ultrasound-guided inter-semispinal plane block in cervical spine surgery
Scientific Title
Ultrasound-guided inter-semispinal plane block versus surgical wound infiltration in perioperative analgesia for cervical spine surgery: A Prospective Randomized Controlled Trial
Scientific Title:Acronym
Postoperative analgesic effect of ultrasound-guided inter-semispinal plane block in cervical spine surgery
Region
| Japan |
Condition
Condition
Cervical spondylosis
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the analgesic effect of inter-semispinal plane (ISP) block in cervical spine surgery with that of wound infiltration and to determine its effect on postoperative analgesic consumption and quality of recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fentanyl consumption during the first 24 hours postoperatively
Key secondary outcomes
Numerical Raring Scale, Time to first rescue analgesic use, Number of adjunctive analgesics use, Frequency of postoperative nausea and vomiting, Postoperative Recovery Quality Score (QoR15)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided inter-semispinal plane block
Interventions/Control_2
Surgical wound innfiltration
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for cervical spine surgery who meet the following criteria
1) 18 to 85 years of age
2) ASA classification 1-3
3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1) Patients with a history of allergy to local anesthetics
2) Patients with a BMI of 35 or more or weighing less than 40 kg
3) Patients under 18 years of age or over 86 years of age
4) Regular users of strong opioid analgesics
5) Patients allergic to acetaminophen, NSAIDs, or fentanyl
6) Patients with communication difficulties
7) Patients with severe renal dysfunction (eGFR<30)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Taketa |
Organization
Ehime Prefectural Central Hospital
Division name
Department of anesthesiology and critical care (Pain Management Clinic)
Zip code
790-0024
Address
83 Kasuga-machi Matsuyama-city Ehime
TEL
+81-89-947-1111
suko1231@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Taketa |
Organization
Ehime Prefectural Central Hospital
Division name
Department of anesthesiology and critical care
Zip code
790-0024
Address
83 Kasuga-machi Matsuyama-city Ehime
TEL
+81-89-947-1111
Homepage URL
suko1231@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Ehime Prefectural Central Hospital
Address
83 Kasuga-machi Matsuyama-city Ehime
Tel
+81-89-947-1111
c-volunteer@eph.pref.ehime.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
| 2023 | Year | 10 | Month | 01 | 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
| 2023 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059287
