UMIN-CTR Clinical Trial

Basic information
Public title	Incidences of Postoperative Complications After Ultrasound-Guided Trigeminal Nerve Blocks
Acronym	Incidences of Postoperative Complications of TNB
Scientific Title	Incidences of Postoperative Complications After Ultrasound-Guided Inferior Alveolar Nerve and Maxillary Nerve Blocks: A Multi-Institutional Retrospective Study
Scientific Title:Acronym	Incidences of Postoperative Complications After Ultrasound-Guided IANB and MNB
Region	Japan

Condition
Condition	Maxillofacial surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In addition to traditional analgesic methods, ultrasound-guided inferior alveolar nerve blocks (IANBs) and ultrasound-guided maxillary nerve blocks (MNBs) may be used as new approaches for pain relief in the maxillofacial region. As these nerve blocks are not commonly used, their safety has not been verified. In this study, we aimed to retrospectively investigate the complication rates of these procedures.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Local anaesthetic toxicity, allergies, neuropathy, movement disorders, pain in the punctured area, infection, sensory deficits, and others were considered possible complications.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	1 months-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	We performed this study on all patients who underwent ultrasound-guided IANBs and MNBs between 1 April 2018 and 31 March 2021. Eligible patients were identified from the database of clinical records. We included patients who received ultrasound-guided IANBs and MNBs and excluded those whose postoperative course was not well documented.
Key exclusion criteria	We excluded the patients that we couldn't follow.
Target sample size	267

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Kojima
Organization	Asahi General Hospital
Division name	Department of Anesthesiology
Zip code	289-2511
Address	Asahi city I-1326
TEL	0479638111
Email	cojicoji1109@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Kojima
Organization	Asahi General Hospital
Division name	Department of Anesthesiology
Zip code	289-2511
Address	Asahi city I-1326
TEL	0479638111
Homepage URL
Email	cojicoji1109@gmail.com

Sponsor
Institute	Asahi General Hospital
Institute
Department

Funding Source
Organization	None.
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	Kagoshima university hospital
Address	8-35-1 Sakuragaoka, Kagoshima 890-8544, Kagoshima Prefecture, Japan
Tel	099-275-6288
Email	cojicoji1109@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	2021072005 2021-08
Org. issuing International ID_1	Asahi General Hospital (approval number: 2021072005), and Kagoshima City Hospital (approval number: 2021-08)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 28 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	267
Results	A total of 164 patients received 282 ultrasound-guided IANBs, and 103 patients received 167 ultrasound-guided MNBs. In the IANB group, no long-term complications were observed, and short-term complications occurred in 6 cases.
Results date posted	2021 Year 09 Month 27 Day
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	Completed
Date of protocol fixation	2021 Year 03 Month 31 Day
Date of IRB	2021 Year 07 Month 20 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None.

Management information
Registered date	2021 Year 09 Month 27 Day
Last modified on	2021 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052043