Local AnesthesiaPhase 3NCT02226913
Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis
A Phase 3 study testing 2% lidocaine with 1:80,000 epinephrine and sodium bicarbonate in people with Local Anesthesia, run by Masoud Saatchi.
Trial summary
Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- 2% lidocaine with 1:80,000 epinephrine and sodium bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Sep 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Who cannot join
- younger than 18 years old
- history of significant medical conditions
- allergies to local anesthetics or sulfites
- pregnancy
- taking any medications that might influence anesthetic assessment
- active sites of pathosis in area of injection
- inability to give informed consent
About this study
Official title: Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study
Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
Read the detailed description
Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.
- Conditions
- Local Anesthesia
- Being tested
- 2% lidocaine with 1:80,000 epinephrine, sodium bicarbonate, placebo
- Keywords
- Buffered, inferior alveolar nerve block, irreversible pulpitis, local anesthesia, sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% lidocaine with 1:80,000 epinephrineDrug
Also called Lignospan; Septodont, Saint Maur des Fosses, France
2% lidocaine with 1:80,000 epinephrine
sodium bicarbonateDrug
Also called Samen Laboratories (Mashhad, Iran)
8.4% sodium bicarbonate
placeboDrug
Also called sterile distilled water (Samen Pharmaceutical Co, Iran)
sterile distilled water (Samen Pharmaceutical Co, Iran)
| Study group | Role | What they receive |
|---|---|---|
| lidocaine & sodium bicarbonate | Experimental | 2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate Receives: Drug: 2% lidocaine with 1:80,000 epinephrine; Drug: sodium bicarbonate |
| lidocaine & placebo | Active comparator | 2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water Receives: Drug: 2% lidocaine with 1:80,000 epinephrine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Measured: Baseline
Secondary outcomes (1)
Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masoud Saatchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Masoud Saatchi, Isfahan University of Medical Sciences
- Investigators
- Masoud Saatchi, DDS MSc, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226913
- Sponsor's protocol ID
- 193396
- Status last verified
- Aug 2016
- First submitted
- 2 Jul 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT02226913
- Acronym / sponsor ID
- 193396
- Conditions
- Local Anesthesia
- Keywords
- Buffered, inferior alveolar nerve block, irreversible pulpitis, local anesthesia, sodium bicarbonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Masoud SaatchiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Aug 2014 (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.
Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
Detailed description
Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine & sodium bicarbonate | Experimental | Drug: 2% lidocaine with 1:80,000 epinephrine, Drug: sodium bicarbonate2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate |
| lidocaine & placebo | Active comparator | Drug: 2% lidocaine with 1:80,000 epinephrine, Drug: placebo2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Key exclusion criteria (7 listed)
- younger than 18 years old
- history of significant medical conditions
- allergies to local anesthetics or sulfites
- pregnancy
- taking any medications that might influence anesthetic assessment
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 |
|---|---|---|
| 2% lidocaine with 1:80,000 epinephrineAlso: Lignospan; Septodont, Saint Maur des Fosses, France2% lidocaine with 1:80,000 epinephrine | Drug | lidocaine & placebo, lidocaine & sodium bicarbonate |
| sodium bicarbonateAlso: Samen Laboratories (Mashhad, Iran)8.4% sodium bicarbonate | Drug | lidocaine & sodium bicarbonate |
| placeboAlso: sterile distilled water (Samen Pharmaceutical Co, Iran)sterile distilled water (Samen Pharmaceutical Co, Iran) | Drug | lidocaine & placebo |
Primary outcome
Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Time frame: Baseline
1 secondary outcome
Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Local Anesthesia
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
Masoud Saatchi, DDS MSc study chair
Isfahan University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% lidocaine with 1:80,000 epinephrine and sodium bicarbonate in people with Local Anesthesia, run by Masoud Saatchi.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block (time frame: Baseline). 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 31 Aug 2016.