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Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation

Primary Purpose

Pain Management, Cervical Preparation

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lidocaine Gel (2%)

Lidocaine Paracervical Block (1%)

About this trial

This is an interventional treatment trial for Pain Management, Cervical Preparation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women 18 and older
Intrauterine pregnancy ≥16 weeks gestation
English speaking competency
Willing and able to sign consent forms
Agree to comply with study procedures

Exclusion Criteria:

Women less than 18 years of age
IV conscious sedation
Known allergy to study medication (lidocaine)
Any women not meeting inclusion criteria above will be excluded from participation

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-administered Gel

Paracervical Block

Arm Description

Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure

Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02852434

First Posted

June 20, 2016

Last Updated

June 5, 2019

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT02852434

Brief Title

Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation

Official Title

Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D&E) to paracervical block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Management, Cervical Preparation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-administered Gel

Arm Type

Experimental

Arm Description

Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure

Arm Title

Paracervical Block

Arm Type

Active Comparator

Arm Description

Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement

Intervention Type

Drug

Intervention Name(s)

Lidocaine Gel (2%)

Intervention Type

Drug

Intervention Name(s)

Lidocaine Paracervical Block (1%)

Primary Outcome Measure Information:

Title

Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion

Description

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.

Time Frame

Intraoperative; Immediately (0-30 seconds) following cervical dilation

Secondary Outcome Measure Information:

Title

Anticipated Pain Measured by Visual Analogue Scale

Description

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.

Time Frame

Preoperative; 30 minutes prior to procedure

Title

Baseline Pain Measured by Visual Analogue Scale

Description

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.

Time Frame

Immediately prior to procedure

Title

Speculum Placement Measured by Visual Analogue Scale

Description

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.

Time Frame

Intraoperative; Immediately following speculum placement

Title

Overall Pain Measured by Visual Analogue Scale

Description

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.

Time Frame

Postoperative; Assessed once 10 minutes after procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women 18 and older Intrauterine pregnancy ≥16 weeks gestation English speaking competency Willing and able to sign consent forms Agree to comply with study procedures Exclusion Criteria: Women less than 18 years of age IV conscious sedation Known allergy to study medication (lidocaine) Any women not meeting inclusion criteria above will be excluded from participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Principal Investigator, MD, MS

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30500336

Citation

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.

Results Reference

derived

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Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation

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