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NCT01304082 · ClinicalTrials.gov registry record · NA
Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT01304082: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT01304082 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01304082, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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).
Interventions
- DRUG Lidocaine
- DRUG normal saline
- DRUG alkalinized lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-11 |
| Phase | NA |
Why NCT01304082 stopped before completion
NCT01304082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Lidocaine is the first listed.
NCT01304082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01304082 about?
NCT01304082 is a clinical study titled "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 administrat...
What is the current status of trial NCT01304082?
This trial is currently terminated. It is a NA study. The enrollment target is 29 participants. The study started on 2011-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01304082?
The interventions under investigation include: Lidocaine (DRUG), normal saline (DRUG), alkalinized lidocaine (DRUG).
Who is sponsoring clinical trial NCT01304082?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01304082's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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