Paracervical Block Before Intrauterine Device (IUD) Insertion

Northwestern University

Status: Completed

Conditions: Pain Control for Intrauterine Device Insertions

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01207401

STU00020958

Details and patient eligibility

About

The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women age 18 -50 years
• A negative urine pregnancy test and clinically unlikely to be pregnant
• Seeking an intrauterine device for any indication
• Willing and able to sign an informed consent in English

Exclusion criteria

• History of a prior IUD successful insertion
• Previous failed insertion of an IUD
• Known copper allergy
• Known levonorgestrel allergy
• Known lidocaine allergy
• Current cervicitis
• Pelvic Inflammatory Disease (PID) within 3 months
• Pregnancy within six weeks prior to IUD insertion
• Uterine anomaly or distortion of the uterine cavity
• Use of any other pain medication within 6 hours prior to IUD insertion
• Use of misoprostol within 24 hours prior to IUD insertion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Paracervical Block

Experimental group

Treatment:

Drug: Lidocaine

No Paracervical Block

No Intervention group