Ultrasound-guided Inferior Alveolar Nerve Block Study

NCT03748329 | Completed DMC

• 1 other identifier: 34854
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Ultrasound; Local Anesthetic

Outcome Measures

Primary Outcomes (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.

  Immediate

Secondary Outcomes (2)

• Pain

  Immediate

• Comfort of ultrasound

  Immediate

Interventions

Ultrasound DEVICE

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Toronto: lead
• Anesthesia Research Foundation: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The transducer will remain in place during the performance of the block but the monitor will be above the head of the patient in the 12 o'clock position so as to not be in direct view.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Student in Dental Anaesthesiology

Model Details: Split mouth study

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: November 20, 2018
• Study Start: January 8, 2018
• Primary Completion: January 29, 2018
• Study Completion: February 2, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)