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10% Lidocaine Spray for Intrauterine Device Insertion (LidocaineIUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870711
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Intrauterine Device Drug: lidocaine spray Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 10% Lidocaine Spray for Pain Control During Intrauterine Device Insertion: A Randomized, Double-blinded, Placebo Controlled Trial
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 17, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group A
10% lidocaine spray
Drug: lidocaine spray
10% lidocaine spray 4 puffs
Other Name: Xylocaine

Placebo Comparator: group B
sterile water
Drug: Placebo
Sterile water 4 puffs
Other Name: Sterile water




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Side effects of 10% Lidocaine spray [ Time Frame: 20 minutes after the procedure ]
    Presence or absence of side effects



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870711


Locations
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Thailand
Nalinee Panichyawat
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nalinee Panichyawat Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03870711    
Other Study ID Numbers: Si 240/2018
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mahidol University:
Intrauterine device
lidocaine spray
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action