Trial · NCT04254081
Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion
NCT04254081, Phase 4, Completed, University of California, San Diego; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion. Trials, record NCT04254081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04254081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion
- NCT number
- NCT04254081
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 57 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Procedural Pain, Buprenorphine, Adjuvants, Anesthesia, Dilation and Evacuation, Analgesics
- Interventions
- Buprenorphine 0.15 MG, Lidocaine 1% Injectable Solution
- First posted
- 2020-02-05
- Last updated
- 2023-08-01
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Score at the Time of Osmotic Dilator Insertion | Assessed immediately after last dilator inserted | Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale at the time of osmotic dilator insertion |
| Secondary | Pain Score 2 Hours After Osmotic Dilator Insertion | 2 hours after osmotic dilator insertion | Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 2 hours after osmotic dilator insertion assessed via text message |
| Secondary | Pain Score 1 Hour After Osmotic Dilator Insertion | 1 hour after osmotic dilator insertion | Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 1 hour after osmotic dilator insertion assessed via text message |
| Secondary | Pain Score 6 Hours After Osmotic Dilator Insertion | 6 hours after osmotic dilator insertion | Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 6 hours after osmotic dilator insertion assessed via text message |
| Secondary | Overall Satisfaction Scores | Morning of D&E procedure: after check-in, before D&E | To determine patient satisfaction with pain control during and after osmotic dilator insertion. This was assessed on the morning of D\&E procedure. Participants following question and rated responses on a Likert scale: What was your overall satisfaction with the amount of pain control that you had during the procedure? |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Score at the Time of Osmotic Dilator Insertion | Assessed immediately after last dilator inserted | score on a scale | MEDIAN | |
| SECONDARY | Pain Score 2 Hours After Osmotic Dilator Insertion | 2 hours after osmotic dilator insertion | score on a scale | MEDIAN | |
| SECONDARY | Pain Score 1 Hour After Osmotic Dilator Insertion | 1 hour after osmotic dilator insertion | score on a scale | MEDIAN | |
| SECONDARY | Pain Score 6 Hours After Osmotic Dilator Insertion | 6 hours after osmotic dilator insertion | score on a scale | MEDIAN | |
| SECONDARY | Overall Satisfaction Scores | Morning of D&E procedure: after check-in, before D&E | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Score at the Time of Osmotic Dilator Insertion | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 3.5 | Inter-Quartile Range 1 to 6 | score on a scale | |
| Pain Score at the Time of Osmotic Dilator Insertion | 1% Lidocaine Paracervical Block | 4.0 | Inter-Quartile Range 2 to 7 | score on a scale | |
| Pain Score 2 Hours After Osmotic Dilator Insertion | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 3 | Inter-Quartile Range 1 to 5 | score on a scale | |
| Pain Score 2 Hours After Osmotic Dilator Insertion | 1% Lidocaine Paracervical Block | 3.5 | Inter-Quartile Range 1 to 5 | score on a scale | |
| Pain Score 1 Hour After Osmotic Dilator Insertion | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 2 | Inter-Quartile Range 1 to 3 | score on a scale | |
| Pain Score 1 Hour After Osmotic Dilator Insertion | 1% Lidocaine Paracervical Block | 3.5 | Inter-Quartile Range 1.75 to 5.25 | score on a scale | |
| Pain Score 6 Hours After Osmotic Dilator Insertion | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 3 | Inter-Quartile Range 1.75 to 5.25 | score on a scale | |
| Pain Score 6 Hours After Osmotic Dilator Insertion | 1% Lidocaine Paracervical Block | 3 | Inter-Quartile Range 0.5 to 4.5 | score on a scale | |
| Overall Satisfaction Scores | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | Very Satisfied | 14 | Participants | |
| Overall Satisfaction Scores | 1% Lidocaine Paracervical Block | Very Satisfied | 13 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 28 | |
| Overall Study | STARTED | 1% Lidocaine Paracervical Block | 29 | |
| Overall Study | COMPLETED | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 28 | |
| Overall Study | COMPLETED | 1% Lidocaine Paracervical Block | 29 | |
| Overall Study | NOT COMPLETED | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 0 | |
| Overall Study | NOT COMPLETED | 1% Lidocaine Paracervical Block | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 0 | 28 |
| Total, all-cause mortality | 1% Lidocaine Paracervical Block | 0 | 29 |
| Total, other adverse events | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 0 | 28 |
| Total, other adverse events | 1% Lidocaine Paracervical Block | 0 | 29 |
| Total, serious adverse events | Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 0 | 28 |
| Total, serious adverse events | 1% Lidocaine Paracervical Block | 0 | 29 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block vs 1% Lidocaine Paracervical Block: deaths from any cause | Trial comparisons |
| Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block vs 1% Lidocaine Paracervical Block: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04254081
GET https://conductscience.org/api/trials/v1/NCT04254081/registered