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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043607
Receipt No. R000049784
Scientific Title Analgesic effects of ultrasound-guided maxillary nerve block and inferior alveolar nerve block for upper and lower orthognathic surgery: a randomized controlled trial
Date of disclosure of the study information 2021/03/13
Last modified on 2021/07/19

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Basic information
Public title Analgesic effects of ultrasound-guided maxillary nerve block and inferior alveolar nerve block for upper and lower orthognathic surgery: a randomized controlled trial
Acronym Analgesic effects of ultrasound-guided maxillary nerve block and inferior alveolar nerve block for upper and lower orthognathic surgery
Scientific Title Analgesic effects of ultrasound-guided maxillary nerve block and inferior alveolar nerve block for upper and lower orthognathic surgery: a randomized controlled trial
Scientific Title:Acronym Analgesic effects of ultrasound-guided maxillary nerve block and inferior alveolar nerve block for upper and lower orthognathic surgery
Region
Japan

Condition
Condition vertical jaw deformities
Classification by specialty
Anesthesiology Dental medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will evaluate the safety of ultrasound-guided maxillary nerve block and inferior alveolar nerve block in patients undergoing vertical jaw deformities by measuring blood levels of local anesthetics and randomly assigning subjects to the block group and the control group who will not undergo block intervention. We evaluate the effects on the number of analgesics required (primary outcome), pain score, analgesic effect, and quality of postoperative recovery (secondary outcome) for 24 hours after the block. The purpose of this study is to establish a safe and effective analgesic method for orthognathic surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The number of times rescue analgesics are used in the 24 hours following the block.
Key secondary outcomes After the block (1, 5, 15, 30, 60 min), levobupivacaine blood level, NRS at/after return, intraoperative opioid (fentanyl, remifentanil) use, pre-/postoperative QoR-40 scores, time to first analgesic use after discharge, complications of ner ve block (local anesthetic systemic toxicity, hematoma, local infection), respiratory complications in the first 24 hours after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 In the block group, bilateral ultrasound-guided maxillary and inferior alveolar nerve blocks are performed after induction of general anesthesia, and 5 mL each of 0.375% levobupivacaine is administered for a total of 20 mL. The time at which all four nerve blocks are completed is set as 0 minutes, and arterial blood samples are collected at 1, 5, 15, 30, and 60 minutes to measure the blood concentration of levobupivacaine.
Interventions/Control_2 In the control group, no block intervention was performed and no arterial blood sampling was done.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria over 16 years of age
ASA-PS I to III
undergoing upper and lower jaw plastic surgery
Key exclusion criteria Patients who are allergic to the study drug, blood coagulation disorders, chronic opioid use, pregnancy, mental disorders, patients who were not extubated in the operating room after surgery for some reason, and other patients who, at the discretion of the physician in charge, are considered inappropriate for this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Michiaki
Middle name
Last name Yamakage
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code 0608543
Address S1W16, Chuo-ku, Sapporo, Hokkaido
TEL 011-688-9663
Email michiaki_yamakage@icloud.com

Public contact
Name of contact person
1st name Sho
Middle name
Last name Kumita
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code 0608543
Address S1W16, Chuo-ku, Sapporo, Hokkaido
TEL 011-688-9663
Homepage URL
Email todonotumari@me.com

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitami Japanese Red Cross Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sapporo Medical University Hospital Institutional Review Board
Address S1W16, Chuo-ku, Sapporo, Hokkaido
Tel 011-611-2111
Email kouhou-byouin@sapmed.ac.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 札幌医科大学附属病院(北海道),北見赤十字病院(北海道)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 13 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
2021 Year 03 Month 11 Day
Date of IRB
2021 Year 03 Month 11 Day
Anticipated trial start date
2021 Year 03 Month 12 Day
Last follow-up date
2023 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
2021 Year 03 Month 13 Day
Last modified on
2021 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049784

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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