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NCT04254081 · ClinicalTrials.gov registry record · Phase 4
Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
NCT04254081 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 57 participants.
The verdict
NCT04254081, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
Study Summary
Cervical preparation with osmotic dilators is commonly used prior to dilation and evacuation (D\&E) procedures to decrease the risk of complications. Women have described the pain of osmotic dilator insertion as moderate to severe yet there have been few studies aimed at addressing pain during and after osmotic dilator insertion. In addition to the discomfort during insertion, pain after osmotic dilator insertion peaks at 2 hours post-insertion with use of a lidocaine paracervical block. One randomized trial found that use of a paracervical block with 1% buffered lidocaine decreased pain with osmotic dilator insertion compared to a sham block. There are adjunct treatments to optimize analgesia with local anesthetics at a variety of anatomic locations. Buprenorphine, a partial mu-opioid receptor agonist, has been found to increase the quality of the anesthetic at the time of administration and increase the duration of nerve block analgesia at several anatomic sites, though has never been studied as an adjunct in a paracervical block. This has been used extensively in orthopedic surgery with significant prolongation of the local anesthetic effect by almost threefold in some studies. Primary Aim: To compare the mean pain score at the time of osmotic dilator insertion among women randomized to a 1% lidocaine and buprenorphine paracervical block compared to a 1% lidocaine paracervical block alone. Secondary Aim: To compare the mean pain score 2 hours after osmotic dilator insertion among women randomized to a lidocaine and buprenorphine paracervical block compared to a lidocaine paracervical block alone. The investigators hypothesize that in patients undergoing osmotic dilator insertion in preparation for dilation and evacuation, the addition of buprenorphine 0.15mg to a 1% lidocaine paracervical block will be associated with lower mean pain scores at time of osmotic dilator insertion compared to women who receive a 1% lidocaine paracervical block alone.
Interventions
- DRUG Lidocaine 1% Injectable Solution
- DRUG Buprenorphine 0.15 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2021-05-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04254081
The ClinicalTrials.gov registry entry for NCT04254081 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lidocaine 1% Injectable Solution is the first listed.
NCT04254081 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04254081 about?
NCT04254081 is a clinical study titled "Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion". Cervical preparation with osmotic dilators is commonly used prior to dilation and evacuation (D\&E) procedures to decrease the risk of complications. Women have described the pain of osmotic dilator insertion as moderate to severe yet there have been few studies aimed at addressing pain during and a...
What is the current status of trial NCT04254081?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2020-05-28. Estimated completion is 2021-05-04.
What interventions are being tested in trial NCT04254081?
The interventions under investigation include: Lidocaine 1% Injectable Solution (DRUG), Buprenorphine 0.15 MG (DRUG).
Who is sponsoring clinical trial NCT04254081?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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