PainNCT02020551
Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion
A study testing Lidocaine Spray in people with Pain, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Aug 2013
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 Not pregnant Smear negative
Who cannot join
- Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Education and Research Hospital of Medicine
Kayseri, 380210
About this study
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.
- Conditions
- Pain
- Being tested
- Lidocaine Spray, Placebo
- Keywords
- Scores During IUD insertion.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine SprayDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| saline spray application | Placebo comparator | Placebo group Receives: Drug: Placebo |
| lidocaine spray application | Experimental | 2 puff lidocaine spray applicated before IUD insertion Receives: Drug: Lidocaine Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
10 cm VAS scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
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 PainStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gökhan Açmaz, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020551
- Sponsor's protocol ID
- kerhGA
- Status last verified
- Dec 2013
- First submitted
- 11 Dec 2013
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
PubMed 25759418
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT02020551
- Acronym / sponsor ID
- kerhGA
- Conditions
- Pain
- Keywords
- Scores During IUD insertion.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- First posted
- 25 Dec 2013 (estimated)
- 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.
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline spray application | Placebo comparator | Drug: PlaceboPlacebo group |
| lidocaine spray application | Experimental | Drug: Lidocaine Spray2 puff lidocaine spray applicated before IUD insertion |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age >18 Not pregnant Smear negative
Key exclusion criteria (1 listed)
- Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis
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 |
|---|---|---|
| Lidocaine Spray | Drug | lidocaine spray application |
| Placebo | Drug | saline spray application |
Primary outcome
Pain
Time frame: 3 months
10 cm VAS scale
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 25 Dec 2013.
- Derived from this study: PubMed 25759418Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
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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 Lidocaine Spray in people with Pain, run by Kayseri Education 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 1 inclusion and 1 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 25 Dec 2013. 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 (time frame: 3 months). 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 NCT02020551, 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 25 Dec 2013.