Trial · NCT02447029

Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial

NCT02447029, Phase 3, Completed, Stanford University; results first posted 2017-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial. Trials, record NCT02447029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02447029

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
NCT number: NCT02447029
Status: Completed
Phases: Phase 3
Enrollment: 142 participants, actual
Lead sponsor: Stanford University
Conditions: Pregnancy, Unwanted
Interventions: vaginal 2% Xylocaine, standard lidocaine paracervical block
First posted: 2015-05-18
Last updated: 2024-02-14
Results first posted: 2017-07-24

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale	At time of cervical dilation, 30 minutes after lidocaine administration	This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Secondary	Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale	Pain level prior to procedure	This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Secondary	Pain With Speculum Insertion as Measured by a Visual Analog Scale	Pain at time of speculum insertion	This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Secondary	Pain With Tenaculum Placement as Measured by a Visual Analog Scale	Pain at time of tenaculum placement	This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Secondary	Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale	Pain prior to discharge home: 30-45 minutes after completion of procedure	This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Secondary	Overall Satisfaction With Procedure as Measured by a Visual Analog Scale	30-45 minutes after completion of procedure	This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.
Secondary	Overall Complication Rate as Measured by a Count of Participants in Each Group	Rate of complications at the end of the study

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale	At time of cervical dilation, 30 minutes after lidocaine administration	Treated participants were included in the analysis.	units on a scale	MEDIAN
SECONDARY	Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale	Pain level prior to procedure	Treated patients were included in the analysis	units on a scale	MEDIAN
SECONDARY	Pain With Speculum Insertion as Measured by a Visual Analog Scale	Pain at time of speculum insertion	Treated patients were included in the analysis	units on a scale	MEAN
SECONDARY	Pain With Tenaculum Placement as Measured by a Visual Analog Scale	Pain at time of tenaculum placement	All treated patients were included in the analysis	units on a scale	MEAN
SECONDARY	Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale	Pain prior to discharge home: 30-45 minutes after completion of procedure	All treated patients were included in the analysis	units on a scale	MEDIAN
SECONDARY	Overall Satisfaction With Procedure as Measured by a Visual Analog Scale	30-45 minutes after completion of procedure	All treated patients were included in the analysis	units on a scale	MEDIAN
SECONDARY	Overall Complication Rate as Measured by a Count of Participants in Each Group	Rate of complications at the end of the study	All treated patients were analyzed	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale	Active Comparator	68	Inter-Quartile Range 17 to 97	units on a scale
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale	Standard Lidocaine Paracervical Block	65	Inter-Quartile Range 10 to 100	units on a scale
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale	Active Comparator	59	Inter-Quartile Range 3 to 98	units on a scale
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale	Standard Lidocaine Paracervical Block	56	Inter-Quartile Range 12 to 99	units on a scale
Pain With Speculum Insertion as Measured by a Visual Analog Scale	Active Comparator	19.5	Standard Deviation 18.4	units on a scale
Pain With Speculum Insertion as Measured by a Visual Analog Scale	Standard Lidocaine Paracervical Block	22.3	Standard Deviation 19.5	units on a scale
Pain With Tenaculum Placement as Measured by a Visual Analog Scale	Active Comparator	39.8	Standard Deviation 22.3	units on a scale
Pain With Tenaculum Placement as Measured by a Visual Analog Scale	Standard Lidocaine Paracervical Block	32.4	Standard Deviation 24.3	units on a scale
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale	Active Comparator	9	Inter-Quartile Range 0 to 85	units on a scale
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale	Standard Lidocaine Paracervical Block	11.5	Inter-Quartile Range 0 to 90	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Comparator	72
Overall Study	STARTED	Standard Lidocaine Paracervical Block	70
Overall Study	Treated	Active Comparator	69
Overall Study	Treated	Standard Lidocaine Paracervical Block	68
Overall Study	COMPLETED	Active Comparator	69
Overall Study	COMPLETED	Standard Lidocaine Paracervical Block	68
Overall Study	NOT COMPLETED	Active Comparator	3
Overall Study	NOT COMPLETED	Standard Lidocaine Paracervical Block	2

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	Active Comparator
Total, all-cause mortality	Standard Lidocaine Paracervical Block
Total, other adverse events	Active Comparator	0	69
Total, other adverse events	Standard Lidocaine Paracervical Block	0	68
Total, serious adverse events	Active Comparator	0	69
Total, serious adverse events	Standard Lidocaine Paracervical Block	0	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27400015	DERIVED

Source PubMed

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
Active Comparator vs Standard Lidocaine Paracervical Block: Overall Complication Rate as Measured by a Count of Participants in Each Group	Trial comparisons
Active Comparator vs Standard 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02447029

GET https://conductscience.org/api/trials/v1/NCT02447029/registered

API reference For AI assistants