Evaluation of Use of Ultrasound for Greater Palatine Nerve Block and Inferior Alveolar Nerve Blocks: An Open Label Feasibility Study

March 7, 2017 updated by: Sugantha Ganapathy, Lawson Health Research Institute

EVALUATION OF USE OF ULTRASOUND FOR GREATER PALATINE NERVE BLOCK AND INFERIOR ALVEOLAR NERVE BLOCKS: AN OPEN LABEL FEASIBILITY STUDY

Dental anesthesia is routinely performed based on anatomical landmarks which can be variable leading to repeated injections and failure. Ultrasonography can be used to guide these injections by identifying the nerves, accompanying blood vessels and the bony landmarks. 20 healthy adult patients will be selected to receive ultrasound guided greater palatine nerve block (gpn) (10 patients) or inferior alveolar nerve (ian) block (10 patients) depending on the dental procedure they are undergoing. The study will evaluate the feasibility and success rates of the ultrasound guided gpn and ian nerve block.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be done on 10 adult patients belonging to asa physical status 1 or 2 undergoing dental procedures with indications for greater palatine or inferior nerve blocks. The study will be conducted in the dental clinic, university hospital, london health sciences centre. All subjects will receive the letter of information at least 4-6 hours before the study procedure. One of the investigators will obtain an informed consent prior to the procedure. All subjects will be clinically examined to rule out any contraindications to the block such as infection, allergy to local anesthetic and any known coagulopathic disorder. No sedation will be used. The study subjects will be positioned on the dental chair and requested to open the mouth as wide as possible. In patients undergoing dental procedure to the upper teeth posterior to canine, a linear hockey stick probe will be positioned long axis to the palate just medial to the alveolar ridge. A color doppler will be used to identify the greater palatine artery (gpa) and this artery will be traced to the greater palatine (gpn) foramen by moving the probe gradually posteriorly until the greater palatine foramen is visualized and the gpn and the gpa are seen to exit from the foramen. Using an oblique off-plane approach a 25g needle attached to a dental carpule of 2% lidocaine will be inserted to contact the nerve and a total of 1ml of local anesthetic is deposited around the nerve and the needle removed. In patients undergoing a dental procedure in mandible, the ian block will be done with the same probe. The ultrasound probe will be positioned so that it is facing laterally on the buccal mucosa close the retromolar area. A color doppler will be used to identify the inferior alveolar artery and a 25g needle coming in-plane to the probe from the anterior side of the probe will deposit the local anesthetic agent perineurally. Images will be stored pre-injection, during injection and post injection. One of the investigators will test for the sensory block in the distribution of gpn and ian. The sensory anesthesia is graded as no anesthesia, partial anesthesia and complete anesthesia for each of the nerve blocks. The time to perform the blocks and time to block onset will also be noted. The total procedure duration is counted form the time of starting the scan to the time of completion of injection. The block performance duration is documented from the time of starting the needle insertion to the end of injection. Time from the end of injection to onset of sensory analgesia will be considered as the onset time. The blocks will be tested at 2 minutes, 5 minutes and 10 minutes after the injection. For the gpn, the sensory block will be documented on the hard palate from the last molar to the canine on the blocked side specifically at the 1st premolar mesially. The areas that will be tested with the dental probe for ian are the buccal mucosa at the base of the first molar tooth (ian), the lower lip of the blocked side, the tip of the tongue (lingual nerve) as well as the lingual mucosa (lingual nerve ) and the buccal mucosa lateral to the molars on the block side (ian). Occurrence of any local hematoma or paresthesia during the procedure will be documented. The subjects will be contacted over the telephone at 24 hours for any residual paresthesia or numbness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. MALE AND FEMALES PATIENTS
  2. MANDIBULAR OR MAXILLARY DENTAL PROCEDURES IN THE DISTRIBUTION OF GREATER PALATINE OR INFERIOR ALVEOLAR NERVES.
  3. ASA CLASS I, II

Exclusion Criteria:

  1. ASA III AND IV
  2. KNOWN NERVE INJURY OR NEUROPATHIES IN THE INTENDED BLOCK DISTRIBUTION
  3. PATIENTS WITH KNOWN COAGULOPATHY
  4. PATIENTS WITH KNOWN ALLERGY TO LOCAL ANESTHETIC OR THE PRESERVATIVE
  5. PSYCHIATRIC ILLNESSES
  6. LACK OF INFORMED CONSENT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: US guided block
Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance
Procedure: US guided block
Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate of nerve blocks
Time Frame: 10 minutes
the success rate of the blocks will be tested at 2, 5 and 10 minutes following the ultrasound guided injections. no anesthesia at the end of 10 minutes will be termed block failure
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sugantha Ganapathy, FRCPC, Professor, Director, regional and Pain reseaerch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 103294

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