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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044166
Receipt No. R000050431
Scientific Title Analgesic effects of ultrasound-guided maxillary nerve block for tonsillectomy: a prospective randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2021/05/10
Last modified on 2021/05/10

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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