10% Lidocaine Spray for Intrauterine Device Insertion

Mahidol University124 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Contraception Intrauterine Device

Interventions

lidocaine sprayDRUG

10% lidocaine spray 4 puffs

PlaceboDRUG

Sterile water 4 puffs

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nalinee Panichyawat

Ratchathewi, Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: Immediately after the procedure

Secondary Outcomes

Side effects of 10% Lidocaine spray

Presence or absence of side effects

Time frame: 20 minutes after the procedure

Data from ClinicalTrials.gov

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