UMIN-CTR Clinical Trial

Basic information
Public title	Analgesic effects of ultrasound-guided maxillary nerve block for tonsillectomy: a prospective randomized, double-blind, placebo-controlled trial
Acronym	Analgesic effects of ultrasound-guided maxillary nerve block for tonsillectomy: a prospective randomized, double-blind, placebo-controlled trial
Scientific Title	Analgesic effects of ultrasound-guided maxillary nerve block for tonsillectomy: a prospective randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym	Analgesic effects of ultrasound-guided maxillary nerve block for tonsillectomy: 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	In this study, patients undergoing tonsillectomy were randomly assigned to a block group that received an ultrasound-guided maxillary nerve block with local anesthetic or a placebo control group that received saline. A double-blind, randomized, controlled trial will be conducted to evaluate the effects of the VAS on resting and swallowing pain scores (Visual Analog Scale: VAS) (primary outcome), opioid consumption at 24 hours postoperatively, quality of recovery score (QoR-40) at 24 hours postoperatively, postoperative nausea and vomiting, and postoperative respiratory complications (secondary outcome). The aim of this study is to establish a safe and effective analgesic method for tonsillectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	rest visual analog scale (VAS) at returning the ward, 2hr, 4hr, 8hr, 24hr after the returning
Key secondary outcomes	swallowing visual analog scale (VAS) at returning the ward, 2hr, 4hr, 8hr, 24hr after the returning Fentanyl consumption and rescue frequency from extubation to 24 hours postoperatively Quality of recovery score (QoR-40) at 24 hours postoperatively Intraoperative remifentanil use Time from discharge to first rescue administration Time to start postoperative drinking water Time to start postoperative drinking and food intake Incidence of adverse events (local anesthetic poisoning, hematoma formation, local infection, postoperative nausea and vomiting due to nerve block, and hypoxia) Hypoxic events (SpO2<92%, airway-related adverse events requiring tracheal intubation and ventilatory management)

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	Perform ultrasound-guided maxillary nerve block and administer 5 mL each of 0.375% ropivacaine bilaterally. The QoR-40 test is administered to all patients preoperatively, and they are assigned to either the block group or the placebo control group randomly by computer. The allocation supervisor hands an envelope with the results of each group allocation to the operating room pharmacist or nurse, who opens the envelope and fills the syringe with 0.375% ropivacaine or saline according to the results. After induction of general anesthesia and tracheal intubation, ultrasound-guided maxillary nerve blocks are performed, and 5 mL of the syringe-filled drug is administered bilaterally.
Interventions/Control_2	Perform an ultrasound-guided maxillary nerve block and administer 5 mL of saline bilaterally. The QoR-40 test is administered to all patients preoperatively, and they are assigned to either the block group or the placebo control group randomly by computer. The allocation supervisor hands an envelope with the results of each group allocation to the operating room pharmacist or nurse, who opens the envelope and fills the syringe with 0.375% ropivacaine or saline according to the results. After induction of general anesthesia and tracheal intubation, ultrasound-guided maxillary nerve blocks are performed, and 5 mL of the syringe-filled drug is administered bilaterally.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	over 18 years of age ASA-PS I to III undergoing tonsillectomy
Key exclusion criteria	Patients who are allergic to the study drug, blood coagulation disorders, chronic opioid use, supected peripheral neuropathy (e.g., severe diabetes mellitus), 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	44

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	0608543
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	0608543
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	jRCT1011210003
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 10 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 10 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050431