10% Lidocaine Spray for Intrauterine Device Insertion

Contraception Clinical Trial

— LidocaineIUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870711
• Other study ID #: Si 240/2018
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: January 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Intrauterine Device

Intervention

Drug:
• lidocaine spray
10% lidocaine spray 4 puffs
• Placebo
Sterile water 4 puffs

Locations

Country	Name	City	State
Thailand	Nalinee Panichyawat	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects of 10% Lidocaine spray	Presence or absence of side effects	20 minutes after the procedure