UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Acronym	Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Scientific Title	Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym	Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Region	Japan

Condition
Condition	tonsillectomy
Classification by specialty	Oto-rhino-laryngology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate the analgesic effect of ultrasound-guided maxillary nerve block in pediatric patients undergoing palatine tonsillectomy and adenoidectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	FLACC scores immediately after surgery, 2 hours, 4 hours, and 24 hours after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ultrasound-guided maxillary nerve block will be performed and 0.2% ropivacaine will be administered. Consent will be obtained from the patients and their guardians on the day before surgery, and the groups will be randomly assigned. On the day of surgery, midazolam syrup 0.5 mg/kg will be administered 30 minutes before entering the operating room. After entering the operating room, general anesthesia will be induced. Maxillary nerve block with a local anesthetic (0.2% ropivacaine) at a dose of 0.15 mL/kg or local injection of saline at a dose of 0.15 mL/kg is performed according to the allocation on the previous day. As in conventional pain management methods, saline injection by the surgeon is performed immediately before the procedure. The amount of narcotic analgesics used intraoperatively and pain assessment immediately after awakening from anesthesia, at 2 hours, and at 4 hours will be performed. Postoperatively, the patient should be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring tracheal intubation or ventilatory management. From the day after surgery onward, in addition to the usual postoperative rounds, pain assessment should be performed at 24 hours. The patient will be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring intubation or ventilatory management until 24 hours after surgery.
Interventions/Control_2	Ultrasound-guided maxillary nerve block will be performed and saline will be administered. Consent will be obtained from the patients and their guardians on the day before surgery, and the groups will be randomly assigned. On the day of surgery, midazolam syrup 0.5 mg/kg will be administered 30 minutes before entering the operating room. After entering the operating room, general anesthesia will be induced. Maxillary nerve block with a local anesthetic (0.2% ropivacaine) at a dose of 0.15 mL/kg or local injection of saline at a dose of 0.15 mL/kg is performed according to the allocation on the previous day. As in conventional pain management methods, saline injection by the surgeon is performed immediately before the procedure. The amount of narcotic analgesics used intraoperatively and pain assessment immediately after awakening from anesthesia, at 2 hours, and at 4 hours will be performed. Postoperatively, the patient should be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring tracheal intubation or ventilatory management. From the day after surgery onward, in addition to the usual postoperative rounds, pain assessment should be performed at 24 hours. The patient will be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring intubation or ventilatory management until 24 hours after surgery.
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	3 years-old <=
Age-upper limit	7 years-old >=
Gender	Male and Female
Key inclusion criteria	Target patients: Pediatric patients undergoing palatine tonsillectomy and adenoidectomy under general anesthesia Age range: 3-7 years Selection criteria Pediatric patients who will undergo palatine tonsillectomy only Pediatric patients undergoing palatine tonsillectomy and adenoidectomy
Key exclusion criteria	Patients who are allergic to ropivacaine Patients who have an anatomical abnormality in the area where maxillary nerve block is performed. Patients who are judged by the anesthesiologist in charge, the principal investigator, or the sub-investigator to be inappropriate for participation in this study.
Target sample size	42

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 Anesthesioogy
Zip code	060-8543
Address	S1W16, Chuo-ku, Sapporo, Hokkaido
TEL	011-688-9663
Email	chakitomohiro0728@yahoo.co.jp

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	060-8543
Address	S1W16, Chuo-ku, Sapporo, Hokkaido
TEL	011-688-9663
Homepage URL
Email	todonotumari@me.com

Sponsor
Institute	Sapporo Medical University School of Medicine, Department of Anesthesiology
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicine, Department of Anesthesiology
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	Sapporo Medical University Institutional Review Board
Address	S1W16, Chuo-ku, Sapporo, Hokkaido
Tel	011-611-2111
Email	todonotumari@me.com

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCT1011210004
Org. issuing International ID_1	jRCT
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 12 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 04 Month 08 Day
Date of IRB	2021 Year 04 Month 08 Day
Anticipated trial start date	2021 Year 04 Month 08 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 05 Month 12 Day
Last modified on	2021 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050451