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

NCT06009302 | Completed

• 1 other identifier: 12071987
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar; Impacted Teeth

Keywords

dental anesthesia; inferior alveolar nerve; regional anesthesia; ultrasound; mandibular nerve

Outcome Measures

Primary Outcomes (1)

• Time without pain

  first 24 postoperative hours

Secondary Outcomes (3)

• Time of numbness

  first 24 postoperative hours

• Pain level when anesthesia is applied

  first 24 postoperative hours

• Pain level when painkiller is needed

  first 24 postoperative hours

Study Arms (2)

US block of mandibular nerve

EXPERIMENTAL

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.

Procedure: US guided block of mandibular nerve

intraoral block of lower alveolar nerve

ACTIVE COMPARATOR

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

Procedure: Intraoral block of lower alveolar nerve

Interventions

US guided block of mandibular nerve PROCEDURE

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).

US block of mandibular nerve

Intraoral block of lower alveolar nerve PROCEDURE

Block of lower alveolar nerve will be applied intraoraly using articaine+adrenaline

intraoral block of lower alveolar nerve

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-64 years
• horizontally placed lower third molars
• ASA I or II group

You may not qualify if:

• 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

Sponsors & Collaborators

• Varazdin General Hospital: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

Varazdin General Hospital

Varaždin, 42000, Croatia

Location

Related Publications (7)

• 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.

  PMID: 23346335 BACKGROUND

• 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.

  PMID: 3165011 BACKGROUND

• 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.

  PMID: 32064612 BACKGROUND

• 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.

  PMID: 17884802 BACKGROUND

• 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.

  PMID: 30532323 BACKGROUND

• 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.

  PMID: 35162346 BACKGROUND

• Martinus M, Mihaljevic S, Reiner K, Verzak Z, Panic MK, Strahija A, Gluncic V, Lukic IK, Lukic A. Analgesic effect of ultrasound-guided extraoral mandibular nerve block compared to intraoral conductive block of the inferior alveolar nerve after lower third molar alveolectomy: a clinical prospective study. BMC Oral Health. 2024 Sep 4;24(1):1041. doi: 10.1186/s12903-024-04787-5.

  PMID: 39232703 DERIVED

Related Links

• Side effect of glucosaimine to coagulation
• The use of analgesics and anti-inflammatories in an oral surgery service in Medellín, Colombia, 2013-2015

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)