Intrauterine Lidocaine for Laminaria

Phase 1

Completed

• Conditions: Abortion, Induced; Pain Management
• Interventions: Drug: Normal Saline; Drug: Lidocaine

• Registration Number: NCT01541293
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Study Start: 2012-09
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrauterine Saline	Normal Saline	Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
Intrauterine Lidocaine	Lidocaine	The experimental arm will receive 100mg lidocaine (5mL of 2% concentration) instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Primary Outcome Measures

Name	Time	Method
Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale	Immediately following laminaria insertion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States