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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047606
Receipt No. 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 2022/04/27

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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 ・PCA usage up to 24 hours after
・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
80 years-old >=
Gender Male and Female
Key inclusion criteria ASA-PS1-2 patients weighing 50-80 kg 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
Email 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
Email yoterao@nagasakih.johas.go.jp

Sponsor
Institute Nagasaki Rosai Hospital
Institute
Department

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
Email 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 04 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054286

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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