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Completed

NCT Number: NCT02904915

Paracervical Block Versus No Paracervical Block During IUD Insertion

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.

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Key information

Conditions

Analgesia Agnosia IUD Insertion Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Other names: xylocaine, lignocaine

No analgesia

Other

IUD placement without analgesia.

Intrauterine Device (IUD)

Device

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

Primary outcomes

  1. Pain Score as Assessed by a Visual Analogue Scale (VAS)

    Time frame: baseline (about 30 seconds after insertion of the speculum)

    The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).

    The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

  2. Pain Score as Assessed by a Visual Analogue Scale

    Time frame: about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum)

    The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).

    The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

  3. Pain Score as Assessed by a Visual Analogue Scale

    Time frame: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)

    The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).

    The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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