Greater Palatine Nerve BlockNCT01870232
Evaluation of Use of Ultrasound for Greater Palatine Nerve Block and Inferior Alveolar Nerve Blocks: An Open Label Feasibility Study
A study testing US guided block in people with Greater Palatine Nerve Block and Inferior Alveolar Nerve Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Greater Palatine Nerve Block, Inferior Alveolar Nerve Block
- What is being tested?
- US guided block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MALE AND FEMALES PATIENTS
- MANDIBULAR OR MAXILLARY DENTAL PROCEDURES IN THE DISTRIBUTION OF GREATER PALATINE OR INFERIOR ALVEOLAR NERVES.
- ASA CLASS I, II
Who cannot join
- ASA III AND IV
- KNOWN NERVE INJURY OR NEUROPATHIES IN THE INTENDED BLOCK DISTRIBUTION
- PATIENTS WITH KNOWN COAGULOPATHY
- PATIENTS WITH KNOWN ALLERGY TO LOCAL ANESTHETIC OR THE PRESERVATIVE
- PSYCHIATRIC ILLNESSES
- LACK OF INFORMED CONSENT.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre University Hospital
London, Ontario, N6A 5A5
About this study
Official title: 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.
Read the 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.
- Being tested
- US guided block
- Keywords
- Greater palatine nerve Block, Inferior Alveolar nerve block, dental anesthesia, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided blockProcedure or surgery
Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance
| Study group | Role | What they receive |
|---|---|---|
| US guided block | Experimental | Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance Receives: Procedure: US guided block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of nerve blocks
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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Palatine Nerve BlockStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugantha Ganapathy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Sugantha Ganapathy, FRCPC, Principal investigator, Professor, Director, regional and Pain reseaerch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870232
- Sponsor's protocol ID
- 103294
- Status last verified
- Mar 2017
- First submitted
- 3 Jun 2013
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF USE OF ULTRASOUND FOR GREATER PALATINE NERVE BLOCK AND INFERIOR ALVEOLAR NERVE BLOCKS: AN OPEN LABEL FEASIBILITY STUDY
- ClinicalTrials.gov ID
- NCT01870232
- Acronym / sponsor ID
- 103294
- Keywords
- Greater palatine nerve Block, Inferior Alveolar nerve block, dental anesthesia, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US guided block | Experimental | Procedure: US guided blockGreater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MALE AND FEMALES PATIENTS
- MANDIBULAR OR MAXILLARY DENTAL PROCEDURES IN THE DISTRIBUTION OF GREATER PALATINE OR INFERIOR ALVEOLAR NERVES.
- ASA CLASS I, II
Key exclusion criteria (6 listed)
- ASA III AND IV
- KNOWN NERVE INJURY OR NEUROPATHIES IN THE INTENDED BLOCK DISTRIBUTION
- PATIENTS WITH KNOWN COAGULOPATHY
- PATIENTS WITH KNOWN ALLERGY TO LOCAL ANESTHETIC OR THE PRESERVATIVE
- PSYCHIATRIC ILLNESSES
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US guided blockGreater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance | Procedure or surgery | US guided block |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sugantha Ganapathy, FRCPC principal investigator
Professor, Director, regional and Pain reseaerch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guided block in people with Greater Palatine Nerve Block and Inferior Alveolar Nerve Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 9 Mar 2017. 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?
Results are not available in the source record.
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?
Success rate of nerve blocks (time frame: 10 minutes). 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 9 Mar 2017.