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

NCT ID: NCT07155785

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-05-25

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.

Conditions

Intrauterine Device Migration; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active group

This group received lidocaine spray during intrauterine device application.

Group Type: ACTIVE_COMPARATOR

Lidocain spray

Intervention Type: DRUG

Lidocaine spray as a local anaesthetic agent was applied to the cervix before intrauterine device application.

Placebo group

This group received saline spray during intrauterine device application.

Group Type: PLACEBO_COMPARATOR

Lidocain spray

Intervention Type: DRUG

Lidocaine spray as a local anaesthetic agent was applied to the cervix before intrauterine device application.

Interventions

Lidocain spray

Lidocaine spray as a local anaesthetic agent was applied to the cervix before intrauterine device application.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ergul Demircivi Bor

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medeniyet University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-0285

Identifier Type: -

Identifier Source: org_study_id