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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06009302
Other study ID # 12071987
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source Varazdin General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
US guided block of mandibular nerve
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).
Intraoral block of lower alveolar nerve
Block of lower alveolar nerve will be applied intraoraly using articaine+adrenaline

Locations

Country Name City State
Croatia Varazdin General Hospital Varaždin

Sponsors (2)

Lead Sponsor Collaborator
Varazdin General Hospital Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time without pain first 24 postoperative hours
Secondary Time of numbness first 24 postoperative hours
Secondary Pain level when anesthesia is applied 0-10 on VAS first 24 postoperative hours
Secondary Pain level when painkiller is needed 0-10 on VAS first 24 postoperative hours
See also
  Status Clinical Trial Phase
Completed NCT01002131 - Exact Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography N/A