10% Lidocaine Spray for Intrauterine Device Insertion | NCT03870711

Studies
10% Lidocaine Spray for Intrauterine Device Insertion

NCT03870711

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jan 30, 2020Actual

Enrollment

124Actual

Phase

Phase 4

Conditions

Contraception
Intrauterine Device

Interventions

lidocaine spray
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 17, 2019Actual

Completion Date

Dec 17, 2019Actual

First Submitted Date

May 10, 2018

First Submission Date that Met QC Criteria

Mar 9, 2019

First Posted Date

Mar 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2020

Last Update Posted Date

Jan 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Experimental	10% lidocaine spray	Drug: lidocaine spray
group B	Placebo Comparator	sterile water	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine spray	Drug	10% lidocaine spray 4 puffs	group A	Xylocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nalinee Panichyawat	Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nalinee Panichyawat		Ratchathewi	Bangkok	10400	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32591417	Derived	Panichyawat N, Mongkornthong T, Wongwananuruk T, Sirimai K. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial. BMJ Sex Reprod Health. 2021 Jul;47(3):159-165. doi: 10.1136/bmjsrh-2020-200670. Epub 2020 Jun 26.

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814