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NCT01405768 · ClinicalTrials.gov registry record · Phase 2
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT01405768: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01405768 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01405768, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for their cervical block will experience less injection pain than women who receive plain lidocaine.
Primary Outcome
A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block. Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability. Patient marks on 100-mm
Interventions
- DRUG sodium bicarbonate buffered lidocaine
- DRUG Non-buffered lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01405768 record still lists
NCT01405768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which sodium bicarbonate buffered lidocaine is the first listed.
NCT01405768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01405768 about?
NCT01405768 is a clinical study titled "Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)". Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for their cervical block will experience less injection pain than women who receive plain lidocaine.
What is the current status of trial NCT01405768?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2011-07. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01405768?
The interventions under investigation include: sodium bicarbonate buffered lidocaine (DRUG), Non-buffered lidocaine (DRUG).
Who is sponsoring clinical trial NCT01405768?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01405768's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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