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NCT01421641 · ClinicalTrials.gov registry record · Phase 4
Tenaculum Pain Control Study
A Phase 4 study of Pelvic Pain and Cervical Pain, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT01421641: Completed Phase 4 study of Pelvic Pain and Cervical Pain, sponsored by Oregon Health and Science University.
NCT01421641 is a Phase 4 study of Pelvic Pain and Cervical Pain that has completed, run by Oregon Health and Science University. The registered enrollment target is 74 participants, below the 368-participant average among 23 other Pelvic Pain trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421641, a Phase 4 study of Pelvic Pain and Cervical Pain, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used. The researchers hypothesize that: 1. There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel. 2. Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
Primary Outcome
The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.
Conditions Studied
Interventions
- DRUG Intracervical Lidocaine Injection
- DRUG Topical Lidocaine Gel
Study Locations (1)
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
What the finished NCT01421641 record still lists
NCT01421641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 368-participant average among 23 other Pelvic Pain trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Pelvic Pain appearing as the primary indexed condition, and to 2 interventions - of which Intracervical Lidocaine Injection is the first listed.
NCT01421641 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT01421641 about?
NCT01421641 is a clinical study titled "Tenaculum Pain Control Study". The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women...
What is the current status of trial NCT01421641?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2011-09. Estimated completion is 2012-05.
What conditions does trial NCT01421641 study?
This clinical trial studies the following conditions: Pelvic Pain, Cervical Pain.
What interventions are being tested in trial NCT01421641?
The interventions under investigation include: Intracervical Lidocaine Injection (DRUG), Topical Lidocaine Gel (DRUG).
Who is sponsoring clinical trial NCT01421641?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421641 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01421641's enrollment target sits among peer trials
74 12th of 23 higher than 12 of 23 other Pelvic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Pain 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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