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Insufficient Enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal saline | Placebo Comparator |
| |
| lidocaine | Active Comparator |
| |
| alkalinized lidocaine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 1 ml subcutaneous injection of 0.9% lidocaine, given once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | immediate, upon injection of each solution |
| Measure | Description | Time Frame |
|---|---|---|
| Rank-transformed Time (Seconds) Until Hypoesthesia | Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus | 0-180 seconds after each injection. |
| Rank-transformed Time (Seconds) Until Anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J Wainger, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | C, L, A | control, lidocaine, alkalinized lidocaine |
| FG001 | C, A, L | control, alkalinized lidocaine, lidocaine |
| FG002 | L, C, A | lidocaine, control, alkalinized lidocaine |
| FG003 | A, C, L | alkalinized lidocaine, control, lidocaine |
| FG004 | A, L, C | alkalinized lidocaine, lidocaine, control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant was missing age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Least Squares Mean | 95% Confidence Interval | rank | immediate, upon injection of each solution |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | 1 ml subcutaneous injection 0.9% sodium chloride, given once |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Wainger | Massachusetts General Hospital | 617-726-8810 | bwainger@partners.org |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| normal saline |
| Drug |
1 ml subcutaneous injection 0.9% sodium chloride, given once |
|
| alkalinized lidocaine | Drug | 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate |
|
Rank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus.
| 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). | 1 minute after each injection |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Pain Score | This pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable). | Median | Inter-Quartile Range | units on a scale |
|
alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate |
|
|
|
| Secondary | Rank-transformed Time (Seconds) Until Hypoesthesia | Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus | Posted | Least Squares Mean | 95% Confidence Interval | rank | 0-180 seconds after each injection. |
|
|
|
|
| Secondary | Rank-transformed Time (Seconds) Until Anesthesia | Rank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus. | Posted | Least Squares Mean | 95% Confidence Interval | rank | 0-180 seconds after each injection |
|
|
|
|
| Secondary | 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). | Posted | Least Squares Mean | 95% Confidence Interval | rank | 1 minute after each injection |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Lidocaine | 1 ml subcutaneous injection of 0.9% lidocaine, given once | 0 | 29 | 0 | 29 |
| EG002 | Alkalinized Lidocaine | 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate | 0 | 29 | 0 | 29 |
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| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
|
| Difference compared to lidocaine |
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| Difference compared to lidocaine |
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| Difference compared to lidocaine |
|