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This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D&E) to paracervical block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-administered Gel | Experimental | Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure |
|
| Paracervical Block | Active Comparator | Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Gel (2%) | Drug |
| ||
| Lidocaine Paracervical Block (1%) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Intraoperative; Immediately (0-30 seconds) following cervical dilation |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Preoperative; 30 minutes prior to procedure |
| Baseline Pain Measured by Visual Analogue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30500336 | Derived | Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-administered Gel | Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure Lidocaine Gel (2%) |
| FG001 | Paracervical Block | Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement Lidocaine Paracervical Block (1%) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the protocol are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-administered Gel | Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure Lidocaine Gel (2%) |
| BG001 | Paracervical Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Intraoperative; Immediately (0-30 seconds) following cervical dilation |
|
1 Day (day of procedure)
No data were collected following the day of procedure; Participants who completed the protocol are included in the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-administered Gel | Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure Lidocaine Gel (2%) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stanford University, Department of OB/GYN | Stanford University Division of Family Planning Services and Research | 6507211562 | familyplanningresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2016 | Feb 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Drug |
|
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. |
| Immediately prior to procedure |
| Speculum Placement Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Intraoperative; Immediately following speculum placement |
| Overall Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Postoperative; Assessed once 10 minutes after procedure |
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age | Median | Full Range | weeks |
|
|
|
| Secondary | Anticipated Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Preoperative; 30 minutes prior to procedure |
|
|
|
| Secondary | Baseline Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Participants who completed the protocol are included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Immediately prior to procedure |
|
|
|
| Secondary | Speculum Placement Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Participants who completed the protocol are included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Intraoperative; Immediately following speculum placement |
|
|
|
| Secondary | Overall Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Participants who completed the protocol are included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Postoperative; Assessed once 10 minutes after procedure |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Paracervical Block | Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement Lidocaine Paracervical Block (1%) | 0 | 35 | 0 | 35 | 0 | 35 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Provider Reported Ease of Insertion |
|