NCT03870711

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

May 10, 2018

Last Update Submit

January 29, 2020

Conditions

ContraceptionIntrauterine Device

Keywords

Intrauterine devicelidocaine spray

Outcome Measures

Primary Outcomes (1)

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

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

    Immediately after the procedure

Secondary Outcomes (1)

  • Side effects of 10% Lidocaine spray

    20 minutes after the procedure

Study Arms (2)

group A

EXPERIMENTAL

10% lidocaine spray

Drug: lidocaine spray

group B

PLACEBO COMPARATOR

sterile water

Drug: Placebo

Interventions

lidocaine sprayDRUG

10% lidocaine spray 4 puffs

Also known as: Xylocaine
group A
PlaceboDRUG

Sterile water 4 puffs

Also known as: Sterile water
group B

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nalinee Panichyawat

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Panichyawat N, Mongkornthong T, Wongwananuruk T, Sirimai K. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial. BMJ Sex Reprod Health. 2021 Jul;47(3):159-165. doi: 10.1136/bmjsrh-2020-200670. Epub 2020 Jun 26.

    PMID: 32591417DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nalinee Panichyawat

    Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2018

First Posted

March 12, 2019

Study Start

August 1, 2018

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

TH(1)