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

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Stanford University

Status and phase

Completed
Phase 3

Conditions

Pain Management, Cervical Preparation

Treatments

Drug: Lidocaine Paracervical Block (1%)
Drug: Lidocaine Gel (2%)

Study type

Interventional

Funder types

Other

Identifiers

NCT02852434
IRB-38200

Details and patient eligibility

About

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

Enrollment

72 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Self-administered Gel
Experimental group
Description:
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Treatment:
Drug: Lidocaine Gel (2%)
Paracervical Block
Active Comparator group
Description:
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Treatment:
Drug: Lidocaine Paracervical Block (1%)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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