UMIN-CTR Clinical Trial

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