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

NCT02852434 | Completed Phase 3 Results

• 1 other identifier: IRB-38200
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management, Cervical Preparation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Anticipated Pain Measured by Visual Analogue Scale

  Preoperative; 30 minutes prior to procedure

• Baseline Pain Measured by Visual Analogue Scale

  Immediately prior to procedure

• Speculum Placement Measured by Visual Analogue Scale

  Intraoperative; Immediately following speculum placement

• Overall Pain Measured by Visual Analogue Scale

  Postoperative; Assessed once 10 minutes after procedure

Study Arms (2)

Self-administered Gel

EXPERIMENTAL

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

Drug: Lidocaine Gel (2%)

Paracervical Block

ACTIVE COMPARATOR

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

Drug: Lidocaine Paracervical Block (1%)

Interventions

Lidocaine Gel (2%) DRUG

Self-administered Gel

Lidocaine Paracervical Block (1%) DRUG

Paracervical Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women less than 18 years of age
• IV conscious sedation
• Known allergy to study medication (lidocaine)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 30500336 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stanford University, Department of OB/GYN
• Organization: Stanford University Division of Family Planning Services and Research

familyplanningresearch@stanford.edu

6507211562

Study Officials

• Principal Investigator, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 7, 2019
• Results First Posted: April 17, 2018

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)