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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01304082
The ClinicalTrials.gov registry entry for NCT01304082 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lidocaine is the first listed.
NCT01304082 reports 0 study locations.
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.
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