10% Lidocaine Spray for Intrauterine Device Insertion

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.

Full Title of Study: “10% Lidocaine Spray for Pain Control During Intrauterine Device Insertion: A Randomized, Double-blinded, Placebo Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 17, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: group A
    • 10% lidocaine spray
  • Placebo Comparator: group B
    • sterile water

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nalinee Panichyawat, Principal Investigator, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital

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