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Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars

Primary Purpose

Molar, Impacted Teeth

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
US guided block of mandibular nerve
Intraoral block of lower alveolar nerve
Sponsored by
Varazdin General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar focused on measuring dental anesthesia, inferior alveolar nerve, regional anesthesia, ultrasound, mandibular nerve

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 18-64 years horizontally placed lower third molars ASA I or II group Exclusion Criteria: allergy to local anesthetics local infection at the site of needle puncture parotitis serious liver disease use of antiarrhythmics group III (eg amiodarone), anticoagulant or antithrombotic drugs lactation people who took an analgesic as a preventive measure before coming to the procedure

Sites / Locations

  • Varazdin General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

US block of mandibular nerve

intraoral block of lower alveolar nerve

Arm Description

Extraoral ultrasound-guided block of the mandibular nerve will be performed iusing an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the "out of plane" technique, near the maxillary artery, and after negative aspiration, local anesthetic ropivacaine (0.75%, 2.5 mL) will be applied.

During the intraoral block of the inferior alveolar nerve, the patient will lie with his mouth wide open, and the inferior alveolar, lingual and buccal nerves will be anesthetized using two injections. The anesthetic used will be 40 mg/mL articaine chloride+0.01 mg/mL epinephrine: the planned amount of anesthetic is 2×1.7 mL, and if anesthesia is not achieved, an additional volume of anesthetic will be added as needed, until anesthesia

Outcomes

Primary Outcome Measures

Time without pain

Secondary Outcome Measures

Time of numbness
Pain level when anesthesia is applied
0-10 on VAS
Pain level when painkiller is needed
0-10 on VAS

Full Information

First Posted
August 18, 2023
Last Updated
September 16, 2023
Sponsor
Varazdin General Hospital
Collaborators
Clinical Hospital Centre Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT06009302
Brief Title
Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars
Official Title
Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varazdin General Hospital
Collaborators
Clinical Hospital Centre Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study about the dynamics and effects of different types of blocks (intraoral conduction anesthesia of the alveolar nerve and extraoral US block of the mandibular nerve) for extraction of lower third molars.
Detailed Description
Standard method of anesthesia for extraction of horizontally positioned lower thirdmolars is intraoral conduction anesthesia of the inferior alveolar nerve. However, the analgesiceffect of block is short and it is necessary to use analgesics. In this prospective clinical study,analgesic effect of ultrasound (US) -guided extraoral block of mandibular nerve will beinvestigated, in order to prolong pain-free time and reduce the use of analgesics associated withrisks (bleeding, hepatotoxicity). Characteristics of alveolar nerve block and US block of the mandibular nerve will becompared, such as: pain during application of anesthesia, amount of anesthetic, duration ofanesthesia, need to use analgesics, time to and level of pain when using analgesics, andcomplications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar, Impacted Teeth
Keywords
dental anesthesia, inferior alveolar nerve, regional anesthesia, ultrasound, mandibular nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
US block of mandibular nerve
Arm Type
Experimental
Arm Description
Extraoral ultrasound-guided block of the mandibular nerve will be performed iusing an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the "out of plane" technique, near the maxillary artery, and after negative aspiration, local anesthetic ropivacaine (0.75%, 2.5 mL) will be applied.
Arm Title
intraoral block of lower alveolar nerve
Arm Type
Active Comparator
Arm Description
During the intraoral block of the inferior alveolar nerve, the patient will lie with his mouth wide open, and the inferior alveolar, lingual and buccal nerves will be anesthetized using two injections. The anesthetic used will be 40 mg/mL articaine chloride+0.01 mg/mL epinephrine: the planned amount of anesthetic is 2×1.7 mL, and if anesthesia is not achieved, an additional volume of anesthetic will be added as needed, until anesthesia
Intervention Type
Procedure
Intervention Name(s)
US guided block of mandibular nerve
Intervention Description
Extraoral ultrasound-guided block of the mandibular nerve will be performed in the examined group using an ultrasound device, using ropivacaine (0.75%, 2.5 mL).
Intervention Type
Procedure
Intervention Name(s)
Intraoral block of lower alveolar nerve
Intervention Description
Block of lower alveolar nerve will be applied intraoraly using articaine+adrenaline
Primary Outcome Measure Information:
Title
Time without pain
Time Frame
first 24 postoperative hours
Secondary Outcome Measure Information:
Title
Time of numbness
Time Frame
first 24 postoperative hours
Title
Pain level when anesthesia is applied
Description
0-10 on VAS
Time Frame
first 24 postoperative hours
Title
Pain level when painkiller is needed
Description
0-10 on VAS
Time Frame
first 24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-64 years horizontally placed lower third molars ASA I or II group Exclusion Criteria: allergy to local anesthetics local infection at the site of needle puncture parotitis serious liver disease use of antiarrhythmics group III (eg amiodarone), anticoagulant or antithrombotic drugs lactation people who took an analgesic as a preventive measure before coming to the procedure
Facility Information:
Facility Name
Varazdin General Hospital
City
Varaždin
ZIP/Postal Code
42000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marija Martinus, MD
Phone
+385 99 682 7489
Email
marija.martinus@gmail.com
First Name & Middle Initial & Last Name & Degree
Marija Martinus

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23346335
Citation
Khorshidi Khiavi R, Pourallahverdi M, Pourallahverdi A, Ghorani Khiavi S, Ghertasi Oskouei S, Mokhtari H. Pain control following impacted third molar surgery with bupivacaine irrigation of tooth socket: a prospective study. J Dent Res Dent Clin Dent Prospects. 2010 Fall;4(4):105-9. doi: 10.5681/joddd.2010.027. Epub 2010 Dec 21.
Results Reference
background
PubMed Identifier
3165011
Citation
Fisher SE, Frame JW, Rout PG, McEntegart DJ. Factors affecting the onset and severity of pain following the surgical removal of unilateral impacted mandibular third molar teeth. Br Dent J. 1988 Jun 11;164(11):351-4. doi: 10.1038/sj.bdj.4806453. No abstract available.
Results Reference
background
PubMed Identifier
32064612
Citation
Teoh L, Moses G, McCullough MJ. A review of drugs that contribute to bleeding risk in general dental practice. Aust Dent J. 2020 Jun;65(2):118-130. doi: 10.1111/adj.12751. Epub 2020 Mar 13.
Results Reference
background
PubMed Identifier
17884802
Citation
Plantevin F, Pascal J, Morel J, Roussier M, Charier D, Prades JM, Auboyer C, Molliex S. Effect of mandibular nerve block on postoperative analgesia in patients undergoing oropharyngeal carcinoma surgery under general anaesthesia. Br J Anaesth. 2007 Nov;99(5):708-12. doi: 10.1093/bja/aem242. Epub 2007 Sep 19.
Results Reference
background
PubMed Identifier
30532323
Citation
Kumar A, Sinha C, Kumar A, Kumari P, Mukul SK. Ultrasound-guided trigeminal nerve block and its comparison with conventional analgesics in patients undergoing faciomaxillary surgery: Randomised control trial. Indian J Anaesth. 2018 Nov;62(11):871-875. doi: 10.4103/ija.IJA_256_18.
Results Reference
background
PubMed Identifier
35162346
Citation
Stojanovic S, Buric N, Tijanic M, Todorovic K, Buric K, Buric N, Jovanovic M, Bajagic V. The Assessment of Prolonged Inferior Alveolar Nerve Blockade for Postoperative Analgesia in Mandibular Third Molar Surgery by a Perineural Addition of Dexamethasone to 0.5% Ropivacaine: A Randomized Comparison Study. Int J Environ Res Public Health. 2022 Jan 25;19(3):1324. doi: 10.3390/ijerph19031324.
Results Reference
background
Links:
URL
https://halmed.hr/upl/lijekovi/PIL/Arthryl-1500-mg-prasak-za-oralnu-otopinu-PIL.pdf
Description
Side effect of glucosaimine to coagulation
URL
http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0121-246X2019000100166
Description
The use of analgesics and anti-inflammatories in an oral surgery service in Medellín, Colombia, 2013-2015

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Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars

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