10% Lidocaine Spray for Intrauterine Device Insertion

Phase 4

Completed

• Conditions: Contraception; Intrauterine Device
• Interventions: Drug: lidocaine spray; Drug: Placebo

• Registration Number: NCT03870711
• Lead Sponsor: Mahidol University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-10
• Study Start: 2018-08-01
• Study First Submitted QC: 2019-03-09
• Study First Posted: 2019-03-12
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	lidocaine spray	10% lidocaine spray
group B	Placebo	sterile water

Primary Outcome Measures

Name	Time	Method
Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale	Immediately after the procedure	Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

Secondary Outcome Measures

Name	Time	Method
Side effects of 10% Lidocaine spray	20 minutes after the procedure	Presence or absence of side effects

Trial Locations

Locations (1)

Nalinee Panichyawat; 🇹🇭 Ratchathewi, Bangkok, Thailand