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Completed

NCT Number: NCT03870711

10% Lidocaine Spray for Intrauterine Device Insertion

Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nalinee Panichyawat

Ratchathewi, Bangkok, 10400, Thailand

About this study

Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in several steps during insertion such as applying tenaculum, applying uterine sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this contraceptive method. Previous researches reported mean pain score with using visual analog scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is used before IUD insertion procedure. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Lidocaine is introduced to use for pain relieving in medical procedures with advantages of rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic method that use in obstetrics and gynecology procedures and has favorable efficacy in reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD insertion. In this study, we investigate pain during IUD insertion using lidocaine spray compared with placebo.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Woman who required for Copper T IUD insertion
  • Body mass index 18.5 - 30 kg/m2
  • Communicable with Thai language
  • New IUD user

Exclusion criteria

  • Suspicion of pregnancy
  • Puerperal sepsis/Immediate post-septic abortion
  • Untreated abnormal uterine bleeding
  • Uterine anomaly/abnormal pathology distorting the uterine cavity
  • Current pelvic inflammatory disease
  • Untreated cervicitis/vaginitis
  • Wilson's disease
  • Copper allergy
  • known hypersensitivity to local anaesthetic
  • Analgesic or anxiolytic use within the last 24 h before the procedure

Treatment and study plan

Lidocaine spray

Drug

10% lidocaine spray 4 puffs

Other names: Xylocaine

Placebo

Drug

Sterile water 4 puffs

Other names: Sterile water

Primary outcomes

  1. Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale

    Time frame: Immediately after the procedure

    Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

Secondary outcomes

  1. Side effects of 10% Lidocaine spray

    Time frame: 20 minutes after the procedure

    Presence or absence of side effects

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

10% Lidocaine Spray for Pain Control During Intrauterine Device Insertion: A Randomized, Double-blinded, Placebo Controlled Trial

Acronym: LidocaineIUD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2019
Registry last updated
Jan 30, 2020

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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