Intrauterine Lidocaine for Laminaria

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541293
• Other study ID #: 11-1928
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: May 13, 2014
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced
• Pain Management

Intervention

Drug:
• Lidocaine
100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
• Normal Saline
5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale		Immediately following laminaria insertion	No
Secondary	Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale		24-48 hours after laminaria insertion	No