CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Paracervical Block (PCB) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02219308
NCT02219308N/ACompleted

Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block

University of California, San Diego·interventional·Posted Aug 18, 2014·Updated Nov 1, 2019

In Brief

A clinical study evaluating Paracervical Block (PCB) and No Paracervical Block (Sham PCB) for Pain Due to Intrauterine Contraceptive Device. Completed, enrolled 67 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 18, 2014
Enrollment StartOct 1, 2014
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 11.9 years ago

Interventions

Paracervical Block (PCB)procedure

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

No Paracervical Block (Sham PCB)procedure

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