UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of ultrasound guided bilateral maxillary nerve block for cleft plate surgery
Acronym	Efficacy of maxillary nerve block for cleft plate surgery
Scientific Title	Efficacy of ultrasound guided bilateral maxillary nerve block for cleft plate surgery
Scientific Title:Acronym	Efficacy of maxillary nerve block for cleft plate surgery
Region	Japan

Condition
Condition	cleft plate
Classification by specialty	Anesthesiology Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Cleft plate surgery is so invasive. Thus, the analgesia for cleft surgery is difficult. The purpose of this study is to evaluate the efficacy of ultrasound-guided maxillary nerve block for cleft plate surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to usage of acetaminophen as a rescue analgesia for 24 hour-postoperative period
Key secondary outcomes	Total dose of acetaminophen for 24 hour-postoperative period Respiratory complication for 24 hour-postoperative period

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	6 months-old <=
Age-upper limit	2 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who received cleft plate surgery under general anesthesia. Patients whose information about whether maxillary nerve block was performed or not, and acetaminophen was used at postoperative period can be obtained from anesthetic and medical records.
Key exclusion criteria	Patients who offer the rejection of participation for this study.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Chaki
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Zip code	060-8543
Address	291, South 1, West 16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	chakitomohiro0728@yahoo.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Chaki
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Zip code	0608543
Address	291, South 1, West 16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	chakitomohiro0728@yahoo.co.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Sapporo Medical School of University Hospital
Address	291, South 1, West 16, Chuo-ku, Sapporo
Tel	011-611-2111
Email	chakitomohiro0728@yahoo.co.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	2021 Year 05 Month 28 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 26 Day
Date of IRB	2021 Year 03 Month 26 Day
Anticipated trial start date	2021 Year 03 Month 26 Day
Last follow-up date	2021 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients, who received cleft plate surgery from 2016/4/1 to 2021/3/31 at Sapporo Medical University School Hospital, are the subjects of this study.

Management information
Registered date	2021 Year 05 Month 28 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050663