UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044166 |
|---|---|
| Receipt number | 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 22:20:32 |
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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
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
todonotumari@me.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050431
