10% Lidocaine Spray for Intrauterine Device Insertion (LidocaineIUD)

January 29, 2020 updated by: Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Nalinee Panichyawat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group A
10% lidocaine spray
Drug: lidocaine spray
10% lidocaine spray 4 puffs
Other Names:
  • Xylocaine
PLACEBO_COMPARATOR: group B
sterile water
Drug: Placebo
Sterile water 4 puffs
Other Names:
  • Sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects of 10% Lidocaine spray
Time Frame: 20 minutes after the procedure
Presence or absence of side effects
20 minutes after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Nalinee Panichyawat, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

December 17, 2019

Study Completion (ACTUAL)

December 17, 2019

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

March 9, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 240/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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