Intrauterine Device MigrationLidocaine IUDNCT07155785
The Role of Lidocaine Spray in Reducing Pain During Intrauterine Device Application
A study testing Lidocain spray in people with Intrauterine Device Migration and Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to investigate the effectiveness of the use of local lidocaine spray application to make routine intrauterine intrauterine device application more painless. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Device Migration, Pain
- What is being tested?
- Lidocain spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old patient who comes to have an intrauterine device inserted voluntarily
- The patient who gave consent to participate in the study
Who cannot join
- Patients who cannot have an intrauterine device because of fibroids or cervical stenosis
- Patient who did not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Investigators aimed to investigate the effectiveness of the use of local lidocaine spray application to make routine intrauterine intrauterine device application more painless.
Read the 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
- Being tested
- Lidocain spray
- Keywords
- intrauterine device, pain
- Medical subject headings
- Intrauterine Device Migration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocain sprayDrug
Lidocaine spray as a local anaesthetic agent was applied to the cervix before intrauterine device application.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | This group received lidocaine spray during intrauterine device application. Receives: Drug: Lidocain spray |
| Placebo group | Placebo comparator | This group received saline spray during intrauterine device application. Receives: Drug: Lidocain spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain component
Reduction of the pain felt during application of the intrauterine device
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Jul 2022
- Primary completion20 Feb 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Device MigrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ergul Demircivi Bor, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155785
- Sponsor's protocol ID
- 2022-0285
- Acronym
- Lidocaine IUD
- Status last verified
- Aug 2025
- First submitted
- 13 Mar 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the results of the patients can be shared
Publications
Demircivi E, Yildirim A, Ozel CS, Sari S, Turgut A. The role of lidocaine spray in reducing pain during intrauterine device insertion. BMC Womens Health. 2026 Jan 29;26(1):95. doi: 10.1186/s12905-026-04296-3.
PubMed 41612302
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lidocaine Spray in Reducing Pain During Intrauterine Device Application
- ClinicalTrials.gov ID
- NCT07155785
- Acronym / sponsor ID
- Lidocaine IUD / 2022-0285
- Conditions
- Intrauterine Device Migration, Pain
- Keywords
- intrauterine device, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double blind randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: Lidocain sprayThis group received lidocaine spray during intrauterine device application. |
| Placebo group | Placebo comparator | Drug: Lidocain sprayThis group received saline spray during intrauterine device application. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-45 years old patient who comes to have an intrauterine device inserted voluntarily
- The patient who gave consent to participate in the study
Key exclusion criteria (2 listed)
- Patients who cannot have an intrauterine device because of fibroids or cervical stenosis
- Patient who did not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocain sprayLidocaine spray as a local anaesthetic agent was applied to the cervix before intrauterine device application. | Drug | Active group, Placebo group |
Primary outcome
Pain component
Time frame: 1 hour
Reduction of the pain felt during application of the intrauterine device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 41612302Demircivi E, Yildirim A, Ozel CS, Sari S, Turgut A. The role of lidocaine spray in reducing pain during intrauterine device insertion. BMC Womens Health. 2026 Jan 29;26(1):95. doi: 10.1186/s12905-026-04296-3.
- Individual participant dataSharing planned: No. Only the results of the patients can be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocain spray in people with Intrauterine Device Migration and Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain component (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07155785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.