UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002540
Receipt No. R000003106
Scientific Title Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration, double blind, randomized trial
Date of disclosure of the study information 2009/09/24
Last modified on 2014/03/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration, double blind, randomized trial
Acronym Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration
Scientific Title Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration, double blind, randomized trial
Scientific Title:Acronym Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration
Region
Japan

Condition
Condition Missing tooth of mandibular
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Opioids added local anesthetic solution prolongs analgesia in axillary brachial plexus block,however there were no report about local anesthesia with opioid in maxillo facial arear. When dental injection,sometime ingrease blood pressure and heart rate caused vasoconstrictor. Therefore some dentist prefer plane anesthetic solutions. But they can't use every procedure because no vasoconstrictor solution do not have enough effect time. We will examine the efficacy and safety of IANB for fentanyl added to mepivacaine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Time from injection to disappear anesthetic effect

Incidence of PONV until next day
Key secondary outcomes Successful rate
1=no paine at recovery
2=paine at recovery
3=need extra injection during procedure
4=need extra injection when procedure start
Successful rate=1+2+3/1+2+3+4

Dose of NSAIDs
Dose of NSAIDs until next day

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GroupM
3% Mepivacaine 3.0ml with saline 0.5ml for IANB and 0.5ml saline iv.
1.Eight hour diet beforeprocedure.
2.Take venous line put on regular monitor and BIS
3.Give Oxygen and Nitrous Oxide via nasal canula.
4.Start propofol sedation and IANB
5.Infiltration anesthesia to buccal side by lidocaine with adrenaline
6.If patient have pain,he/she can take roxoprofen Na
Study start 09/10/2009
Study finish 12/31/2010
Interventions/Control_2 GroupFM 3%Mepivacaine3.0mlwith fentanyl 0.5ml for IANB and 0.5ml saline iv

Method is same as group M
Interventions/Control_3 GroupIFM 3%Mepivacaine3.0ml with saline 0.5ml for IANB and 0.5ml fentanyl iv

Method is same as group M
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria There are taken informed concent among dental implant patient under iv sedation at Nippon Dental University hospital.
Key exclusion criteria Bone graft case
Body weight under 40kg
Age under20
Have heart disease overNYHA2
Have lever or kidney disorder
Take tranquilizers regularly
Have drug,bean,egg,allergy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name katsuhisa sunada
Organization The Nippon Dental University
Division name dental anesthesiology
Zip code
Address 1-9-20 fujimi chiyoda Tokyo
TEL 03(3261)8311
Email katsu.sunada@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name katsuhisa sunada
Organization The Nippon Dental University
Division name dental anesthesiology
Zip code
Address 1-9-20 fujimi chiyodaku Tokyo
TEL 03(3261)8311
Homepage URL
Email katsu.sunada@nifty.com

Sponsor
Institute The Nippon Dental University
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 日本歯科大学附属病院

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 24 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 Terminated
Date of protocol fixation
2009 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 24 Day
Last modified on
2014 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.