N/A N=50 Randomized Treatment

Paracervical Block Before Intrauterine Device (IUD) Insertion

Pain Control for Intrauterine Device Insertions

Bottom Line

View on ClinicalTrials.gov: NCT01207401 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcome: Primary: Median Visual Analogue Score Measuring Pain — 12; 8.5; 12; 28 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lidocaine (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Northwestern University
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Visual Analogue Score Measuring Pain	12; 8.5; 12; 28; 40; NA	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01207401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.