Local AnestheticsNCT01304082
Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.
A study testing Lidocaine, normal saline and alkalinized lidocaine in people with Local Anesthetics, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
When one receives a local anesthetic, such as novocaine for a dental procedure, there is a burning painful sensation experienced upon injection of the local anesthetic. We are trying to understand the role of pH (how acidic a solution is) in the production of pain during local anesthetic administration. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Local Anesthetics
- What is being tested?
- Lidocaine, normal saline and alkalinized lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients at MGH Center for Pain Medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints.
Who cannot join
- contraindication to the clinical procedure
- do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.
When one receives a local anesthetic, such as novocaine for a dental procedure, there is a burning painful sensation experienced upon injection of the local anesthetic. We are trying to understand the role of pH (how acidic a solution is) in the production of pain during local anesthetic administration. We hypothesize that less acidic solutions produce less burning. We also want to determine whether or not the pH of the solution affects the rate of onset of the local anesthesia. We will recruit subjects from patients who have a clinical indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve blocks are administered at adjacent spinal levels, typically using either lidocaine or bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part of the research procedure and then provide lidocaine at the control location before continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to compare the effects of the three solutions. There will be almost no deviation from the standard clinical procedure. After the injection of each solution, the pain score on administration of the medication will be recorded immediately. We will also provide a continuous stimulation (pin taps) after the local anesthetic injection and record when the patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation). Finally, we will record the pain score upon reinsertion of a needle to mark the precise location (part of the clinical procedure) one minute after the local anesthetic injection. All data will be collected during the a single clinical visit.
The study will conclude when 60 subjects have successfully been tested. Data will be reviewed annually.
- Conditions
- Local Anesthetics
- Being tested
- Lidocaine, normal saline, alkalinized lidocaine
- Keywords
- pain pH local anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
1 ml subcutaneous injection of 0.9% lidocaine, given once
normal salineDrug
1 ml subcutaneous injection 0.9% sodium chloride, given once
alkalinized lidocaineDrug
1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
| lidocaine | Active comparator | Not described Receives: Drug: Lidocaine |
| alkalinized lidocaine | Experimental | Not described Receives: Drug: alkalinized lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rank-transformed Pain Score
Pain score upon injection of local anesthetic:
the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).
Measured: immediate, upon injection of each solution
Secondary outcomes (3)
Rank-transformed Time (Seconds) Until Hypoesthesia
Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus
Measured: 0-180 seconds after each injection.
Rank-transformed Time (Seconds) Until Anesthesia
Rank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus.
Measured: 0-180 seconds after each injection
Rank-transformed Pain Score Upon Needle Stick.
Pain score upon needle stick:
The pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).
Measured: 1 minute after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Local AnestheticsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Wainger, Massachusetts General Hospital
- Investigators
- Brian J Wainger, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304082
- Sponsor's protocol ID
- 2010-P-000533
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2011
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.
- ClinicalTrials.gov ID
- NCT01304082
- Acronym / sponsor ID
- 2010-P-000533
- Conditions
- Local Anesthetics
- Keywords
- pain pH local anesthetics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When one receives a local anesthetic, such as novocaine for a dental procedure, there is a burning painful sensation experienced upon injection of the local anesthetic. We are trying to understand the role of pH (how acidic a solution is) in the production of pain during local anesthetic administration. We hypothesize that less acidic solutions produce less burning. We also want to determine whether or not the pH of the solution affects the rate of onset of the local anesthesia. We will recruit subjects from patients who have a clinical indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve blocks are administered at adjacent spinal levels, typically using either lidocaine or bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part of the research procedure and then provide lidocaine at the control location before continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to compare the effects of the three solutions. There will be almost no deviation from the standard clinical procedure. After the injection of each solution, the pain score on administration of the medication will be recorded immediately. We will also provide a continuous stimulation (pin taps) after the local anesthetic injection and record when the patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation). Finally, we will record the pain score upon reinsertion of a needle to mark the precise location (part of the clinical procedure) one minute after the local anesthetic injection. All data will be collected during the a single clinical visit.
The study will conclude when 60 subjects have successfully been tested. Data will be reviewed annually.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Drug: normal saline |
| lidocaine | Active comparator | Drug: Lidocaine |
| alkalinized lidocaine | Experimental | Drug: alkalinized lidocaine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients at MGH Center for Pain Medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints.
Key exclusion criteria (2 listed)
- contraindication to the clinical procedure
- do not speak English
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 |
|---|---|---|
| Lidocaine1 ml subcutaneous injection of 0.9% lidocaine, given once | Drug | lidocaine |
| normal saline1 ml subcutaneous injection 0.9% sodium chloride, given once | Drug | normal saline |
| alkalinized lidocaine1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate | Drug | alkalinized lidocaine |
Primary outcome
Rank-transformed Pain Score
Time frame: immediate, upon injection of each solution
Pain score upon injection of local anesthetic: the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).
3 secondary outcomes
Rank-transformed Time (Seconds) Until Hypoesthesia
Time frame: 0-180 seconds after each injection.
Rank-transformed Time (Seconds) Until Anesthesia
Time frame: 0-180 seconds after each injection
Rank-transformed Pain Score Upon Needle Stick.
Time frame: 1 minute after each injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian J Wainger, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, normal saline and alkalinized lidocaine in people with Local Anesthetics, run by Massachusetts General Hospital at 1 site in United States.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Apr 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rank-transformed Pain Score (time frame: immediate, upon injection of each solution). 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 11 Apr 2017.