Intrauterine Lidocaine for Laminaria

University of North Carolina (UNC)

Status and phase: Completed; Phase 1

Conditions: Abortion, Induced; Pain Management

Treatments: Drug: Normal Saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01541293

11-1928

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Intrauterine Lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

Intrauterine Saline

Placebo Comparator group

Description:

Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Treatment:

Drug: Normal Saline