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Pain Control for Intrauterine Device Placement Using Paracervical Block

NCT02219308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-11-01

Study results available
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Summary

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

Conditions

  • Pain Due to Intrauterine Contraceptive Device

Interventions

PROCEDURE

Paracervical Block (PCB)

Drug: 1% Lidocaine Hydrochloride Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle. IUD placement then proceeds

PROCEDURE

No Paracervical Block (Sham PCB)

Drug: 1% Lidocaine Hydrochloride Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain. IUD placement then proceeds

Sponsors & Collaborators

Principal Investigators

  • Sheila Mody, MD MPH · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219308 on ClinicalTrials.gov