UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043607 |
|---|---|
| Receipt number | 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 06:40:09 |
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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
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
todonotumari@me.com
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049784
