UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047606 |
|---|---|
| Receipt number | R000054286 |
| Scientific Title | A study of analgesic effect of local infiltration analgesia with levobupivacaine after cervical laminoplasty. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/09/05 13:21:13 |
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Basic information
Public title
A study of analgesic effect of local infiltration analgesia with levobupivacaine after cervical laminoplasty.
Acronym
A study of analgesic effect of local infiltration analgesia with levobupivacaine after cervical laminoplasty.
Scientific Title
A study of analgesic effect of local infiltration analgesia with levobupivacaine after cervical laminoplasty.
Scientific Title:Acronym
A study of analgesic effect of local infiltration analgesia with levobupivacaine after cervical laminoplasty.
Region
| Japan |
Condition
Condition
cervical spondylosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The degree of pain following cervical laminoplasty is severe, and appropriate postoperative pain management is important. Postoperative pain is caused by multiple factors, including pain from nociceptors, nerves, and inflammation, and it is common to use a combination of analgesics. The current mainstream of analgesia is the use of opioids, mainly fentanyl, but these drugs also have side effects such as postoperative nausea, vomiting, and respiratory depression. With the advent of long-acting local anesthetics, local infiltration of local anesthetics has begun to be applied in various surgeries because it is easy and complication-free. In 2020, a retrospective study reported the efficacy of ropivacaine in cervical vertebroplasty. In this study, we prospectively compare the analgesic effect and opioid reduction effect of levobupivacaine, which is even longer acting than ropivacaine. Local infiltration of local anesthetics is a simple and safe method, and if this study demonstrates its efficacy, it will improve the quality of postoperative management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical rating scale(NRS) immediately after surgery, 1 hour, 2 hours, 6 hours, 12 hours, and 24 hours
Key secondary outcomes
･Frequency of use of rescue drugs
･Circulation, SpO2
･Side effects such as nausea and itching
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
| Medicine |
Interventions/Control_1
Local infiltration anesthesia of the paraspinal muscles, subcutaneous tissue, and skin along the surgical wound using 20 ml of 0.25% levobupivacaine bilaterally at the time of wound closure
Interventions/Control_2
No local infiltration anesthesia
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS1-2 patients who undergo cervical laminoplasty of 3 or more vertebrae
Key exclusion criteria
Patients with liver or kidney dysfunction, ulcers, or asthma
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rosai Hospital
Division name
Department of anesthesia
Zip code
857-0134
Address
2-12-5,Setogoe,Sasebo City, Nagasaki, Japan
TEL
0956-49-2191
yoterao@nagasakih.johas.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rosai Hospital
Division name
Department of anesthesia
Zip code
857-0134
Address
2-12-5,Setogoe,Sasebo City, Nagasaki, Japan
TEL
0956-49-2191
Homepage URL
yoterao@nagasakih.johas.go.jp
Sponsor or person
Institute
Nagasaki Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Research funds to promote the hospital functions of Japan of Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Rosai Hospital
Address
2-12-5,Setogoe,Sasebo City, Nagasaki, Japan
Tel
0956-49-2191
shomu@nagasakih.johas.go.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 | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054286
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