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UltrasoundNCT03748329

Ultrasound-guided Inferior Alveolar Nerve Block Study

A study testing Ultrasound in people with Ultrasound and Local Anesthetic, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique (which historically has an approximate failure rate as high as 33.8%). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Ultrasound, Local Anesthetic
What is being tested?
Ultrasound
How many people
80 participants
Where
1 siteCanada
Study dates
8 Jan 2018to 2 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Inclusion criteria include male and female volunteers been the ages of 18 and 65 years old who can understand the study protocol and are able to give consent. Subjects must weigh between 40 kg and 100kg and fall under the American Society of Anesthesiology (ASA) classification I or II. At least one unrestored tooth distal to the lateral incisor must be present in both mandibular quadrants for EPT testing. Participants must also be able to open their mouth sufficiently to place a transducer and needle against the medial mandibular ramus.

Exclusion criteria include volunteers with serious medical conditions (ASA 3 or higher). Pregnant volunteers and those who have an allergy to mepivicaine or are on systemic anticoagulation will be excluded. Volunteers with infections, lesions, or anatomic anomalies at the site of the injection or have a pre-existing neurologic deficit in the mouth, head, or neck will also be excluded. Other exclusion criteria include volunteers who have taken any CNS depressants, opioids, non-steroidal anti-inflammatories, and/or acetaminophen in the 48 hours prior to testing. Subjects who are unable to speak English AND are unable to provide their own interpreter at all necessary appointments (screening, data collection, follow-up phone call) will be excluded as the data collection requires direct communication with one of the investigators (they are only English speaking) to discuss consent, instruction in the study, and possible post-operative adverse events and their associated management.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

About this study

The primary objective is to compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique (which historically has an approximate failure rate as high as 33.8%). The secondary objective is to demonstrate that delivering a block under ultrasound guidance does not cause any additional pain to patients, as well as to reconfirm data shown in a previous study that the intra-oral transducer is well-tolerated among patients.

Read the detailed description

Inferior alveolar nerve blocks are necessary to perform dental procedures in the mandible. The standard mandibular block (also known as the Halsted Technique, or the Inferior Alveolar Nerve Block) is based on intraoral landmarks but due to anatomical variation between patients, the failure rate, and therefore incomplete anaesthesia of the mandibular teeth, is high. Success rates have been reported anywhere from 66.2%-96.5% (Montagnese, 1984). Different approaches have been described to improve the success of blocking the inferior alveolar nerve but all have had varying rates of success (Blanton, 2002; Todorovic, 1986). Regardless, none are able to consistently and reliably block the inferior alveolar nerve one-hundred percent of the time.

Ultrasound is a valuable clinical tool to improve the accuracy of nerve blocks, and is also an important teaching tool. Ultrasound imaging is capable of identifying the relevant anatomy in the region of interest and has become common place during placement of spinal nerve blocks and many commonly recognized peripheral nerve blocks (Denny et Harrop-Griffiths, 2005). In studies of peripheral nerve blockade of the spine, the use of ultrasound should be able to reduce the number of needle passes required to achieve anaesthesia of a peripheral nerve and has been shown to reduce procedural times (Griffin et Nicholls, 2010). In addition, onset of sensory blockade is faster because of more intimate proximity of the needle tip to the nerve. Finally, the ability to visualize, and thereby ensure, the spread of local anaesthetic around the nerve also aids in the speed of onset of the block (Griffin et Nicholls, 2010). However, ultrasound has yet to be used successfully in intraoral trigeminal nerve blocks.

While Hannan et al. (1999) did compare ultrasonography to traditional landmarking for the inferior alveolar nerve block, there was no increase in success of the block. It should be noted that Hannan et al. was unable to visualize the nerve and instead used the inferior alveolar artery as a surrogate landmark to approximate proximity to the inferior alveolar nerve. Since the study by Hannan et al., there have been marked improvements to ultrasound hardware, i.e. transducers, and software, i.e. processors, to improve resolution and increase the ability to differentiate objects in soft tissue, specifically the neural structures from the vascular structures.

The inferior alveolar nerve itself can now be visualized by ultrasound in unembalmed human cadavers and can be accurately targeted with a needle by placing dye around the inferior alveolar nerve and confirmed by dissection performed by a blinded anatomist (Chanpong, 2013). The same study had a clinician consistently identify the inferior alveolar nerve bilaterally in 20 living individuals by ultrasound. In addition, according to the satisfaction survey performed, the intraoral ultrasound probe was just as comfortable as a bite block placed on the contralateral side. Based on a 10 point Likert scale (1 being very uncomfortable and 10 being very comfortable), the ultrasound probe scored a mean of 7.3 and the bite block a 7.5, and all 20 volunteers were able to complete bilateral scans. Given that the inferior alveolar nerve block can be easily visualized by ultrasound, the accuracy of needle placement may be significantly improved.

Adjacent to the inferior alveolar nerve are the inferior alveolar artery and the inferior alveolar vein. The risk of inadvertent vascular puncture of these vessels while performing an Inferior Alveolar Nerve Block has been reported to be anywhere from 2.6% to 30% (Malamed, 2013). By being able to guide the needle using ultrasound, the incidence of their puncture, and incidence of nerve puncture, may also be reduced.

Finally, it has been noted that when patients experience a painful "electric shock"-like symptom during mandibular block anaesthesia, these events may be a result from direct contact to the lingual nerve (Harn et Durham, 1990). This sensation is said to occur approximately seven percent of the time during mandibular blocks and can be associated with persistent reduced sensation to the trigeminal nerve. Avoiding direct insult to any of the surrounding nerves would reduce intra-operative pain to the patient during inferior alveolar nerve blockade.

In summary, ultrasound-guided inferior alveolar nerve block is a novel technique that may improve the success of the nerve block and reduce inadvertent puncture of surrounding structures. Currently, there is no published description of the use of ultrasound to guide precise needle placement to adjacent proximity of the inferior alveolar nerve to accomplish blockade of the respective nerve in living patients.

Being tested
Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    Will deposit local anaesthetic intra-orally with the aid of ultrasound to guide the location of the final deposition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasound vs Traditionally Landmarked Method

    Compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique using pulpal anaesthesia as assessed by an electric pulp tester.

    Measured: Immediate

Secondary outcomes (2)
  1. Pain

    Demonstrate that delivering a block under ultrasound guidance does not cause any additional pain to patients comparing techniques using a 100mm VAS.

    Measured: Immediate

  2. Comfort of ultrasound

    Reconfirm data shown in a previous study that the intra-oral transducer is well-tolerated among patients comparing techniques using a 100mm VAS.

    Measured: Immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start8 Jan 2018
  3. Primary completion29 Jan 2018
  4. Study completion2 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Single group
Model description
Split mouth study
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748329
Sponsor's protocol ID
34854
Status last verified
Nov 2018
First submitted
18 Aug 2017
Last updated
20 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with Ultrasound and Local Anesthetic, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasound vs Traditionally Landmarked Method (time frame: Immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.

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