Paracervical Block Versus No Paracervical Block During IUD Insertion

NCT ID: NCT02904915

Last Updated: 2018-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-12

Study Completion Date

2017-10-09

Brief Summary

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The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Detailed Description

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Conditions

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Analgesia IUD Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paracervical block

Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.

Intrauterine device (IUD)

Intervention Type DEVICE

IUD placement with or without paracervical block with 1% lidocaine.

No analgesia

IUD placement with no analgesia.

Group Type ACTIVE_COMPARATOR

No analgesia

Intervention Type OTHER

IUD placement without analgesia.

Intrauterine device (IUD)

Intervention Type DEVICE

IUD placement with or without paracervical block with 1% lidocaine.

Interventions

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Lidocaine

Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.

Intervention Type DRUG

No analgesia

IUD placement without analgesia.

Intervention Type OTHER

Intrauterine device (IUD)

IUD placement with or without paracervical block with 1% lidocaine.

Intervention Type DEVICE

Other Intervention Names

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xylocaine, lignocaine

Eligibility Criteria

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Inclusion Criteria

* Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Exclusion Criteria

* Women with current pelvic inflammatory disease (PID)
* Women who are not good candidates for an IUD
* Patients who have a Lidocaine allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Pamela Berens

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela D Berens, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-16-0664

Identifier Type: -

Identifier Source: org_study_id

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