The Role of Lidocaine Spray in Reducing Pain During Intrauterine Device Application

Not Applicable

Completed

• Conditions: Intrauterine Device Migration; Pain
• Interventions: Drug: Lidocain spray

• Registration Number: NCT07155785
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

Investigators aimed to investigate the effectiveness of the use of local lidocaine spray application to make routine intrauterine intrauterine device application more painless.

Detailed Description

As a standard, no anaesthesia is applied to the patient during intrauterine device application in outpatient clinic conditions. Patients can usually tolerate the procedure even if there is minimal pain and discomfort. In patients with low pain tolerance, the procedure can be terminated before the application can be performed and the application can be repeated under local or general anaesthesia. Local anaesthetic sprays are routinely and comfortably used in episiotomy repair, upper gastrointestinal tract endoscopy and intraoral procedures. In our study, investigators aimed to demonstrate the efficacy of local spray anaesthesia without side effects for the relief of pain that occurs in some patients during intrauterine device application by comparing it with placebo.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-02-20
• Study Completion: 2023-05-25
• Study First Submitted: 2024-03-13
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 18-45 years old patient who comes to have an intrauterine device inserted voluntarily
• The patient who gave consent to participate in the study

Exclusion Criteria

• Patients who cannot have an intrauterine device because of fibroids or cervical stenosis
• Patient who did not want to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	Lidocain spray	This group received lidocaine spray during intrauterine device application.
Placebo group	Lidocain spray	This group received saline spray during intrauterine device application.

Primary Outcome Measures

Name	Time	Method
Pain component	1 hour	Reduction of the pain felt during application of the intrauterine device

Trial Locations

Locations (1)

Istanbul Medeniyet University; Istanbul, Turkey (Türkiye)