Clinical trial NCT06009302: 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
Overall status: COMPLETED
Phase: NA
Conditions: Molar
Impacted Teeth
Keywords: dental anesthesia
inferior alveolar nerve
regional anesthesia
ultrasound
mandibular nerve
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Centre Zagreb
First posted: 2023-08-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Time without pain
timeFrame: first 24 postoperative hours
Secondary outcomes:
measure: Time of numbness
timeFrame: first 24 postoperative hours
measure: Pain level when anesthesia is applied
timeFrame: first 24 postoperative hours
measure: Pain level when painkiller is needed
timeFrame: first 24 postoperative hours
Other outcomes:
Locations:
city: Varaždin
country: Croatia
facility: Varazdin General Hospital
Study officials:
References:
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.
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.
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.
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.
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.
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.