Skip to main content
OpenTrials
Completed

NCT Number: NCT01541293

Intrauterine Lidocaine for Laminaria

This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion.

The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a paracervical block.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abortion, Induced Agnosia Dilatation, Pathologic Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Can sign informed consent
  • Healthy pregnant females
  • Weight over 45kg
  • Seeking abortion by dilation and evacuation in the second trimester of pregnancy
  • Gestational age 14-24 weeks confirmed by clinic ultrasound

Exclusion criteria

  • Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent
  • Known allergy or previous reaction to ibuprofen or other NSAID

Treatment and study plan

Lidocaine

Drug

100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

normal saline

Drug

5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Primary outcomes

  1. Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale

    Time frame: Immediately following laminaria insertion

Secondary outcomes

  1. Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale

    Time frame: 24-48 hours after laminaria insertion

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 29, 2012
Registry last updated
May 14, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.