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OpenTrials
Completed

NCT Number: NCT01708330

The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.

Women being treated at the Women & Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.

The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.

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Key information

Conditions

Nonviable Pregnancy Abortion, Incomplete Abortion, Missed Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Women and Infants Hospital Triage

Providence, Rhode Island, 02905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient at the Women and Infants Triage/Women's Emergency Department
  • Vital signs are stable
  • Ages 18 and older
  • Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
  • Estimated gestational age up to 10 weeks
  • Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
  • Able to read English or Spanish
  • Able to give informed consent for involvement in the study

Exclusion criteria

  • Allergic to lidocaine, iodine or betadine
  • Known sensitivity to any component of the lidocaine or placebo gel.
  • In acute distress
  • Unable to give informed consent
  • Unable to read English or Spanish

Treatment and study plan

Lidocaine

Drug

2% Lidocaine gel

Placebo Gel

Drug

odorless, colorless gel will be used as a placebo

Other names: KY Jelly

Primary outcomes

  1. Pain during intracervical block

    Time frame: immediate

    Pain on visual analogue scale

Secondary outcomes

  1. Pain during tenaculum placement

    Time frame: immediate

    Pain on visual analogue scale

  2. Pain during cervical dilation

    Time frame: immediate

    Pain on visual analogue scale

  3. Pain during uterine aspiration

    Time frame: immediate

    Pain on visual analogue scale

Other outcomes

  1. Complications

    Time frame: 1 hour after procedure

Sponsors and collaborators

Lead sponsor

Bridgeport Hospital

Other

Collaborators

  • Women and Infants Hospital of Rhode Island

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 16, 2012
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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