IUD PainPhase 2NCT02658773
Lidocaine-prilocaine Cream on IUD Insertion Pain
A Phase 2 study testing lidocaine-Prilocaine cream in people with IUD Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- IUD Pain
- What is being tested?
- lidocaine-Prilocaine cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jun 2016
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- Women not taken misoprostol prior to IUD insertion
- No contraindication to or history of allergic reaction to lidocaine
- Women who will accept to participate in the study
Who cannot join
- Lidocaine allergy
- Any contraindication to IUD placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cervical Lidocaine-prilocaine Cream on IUD Insertion Pain: A Randomized Controlled Trial
The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.
Read the detailed description
IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.
To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain. Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed.
Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.
- Conditions
- IUD Pain
- Being tested
- lidocaine-Prilocaine cream, placebo cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-Prilocaine creamDrug
placebo creamDrug
| Study group | Role | What they receive |
|---|---|---|
| lidocaine-Prilocaine cream | Active comparator | lidocaine-Prilocaine anesthetic cream placed into their cervix prior to having the IUD inserted Receives: Drug: lidocaine-Prilocaine cream |
| placebo cream | Placebo comparator | an inert placebo cream placed into their cervix Receives: Drug: placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during IUD insertion
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658773
- Sponsor's protocol ID
- LPIUD
- Status last verified
- Aug 2016
- First submitted
- 15 Jan 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Lidocaine-prilocaine Cream on IUD Insertion Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02658773
- Acronym / sponsor ID
- LPIUD
- Conditions
- IUD Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jan 2016 (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.
The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.
Detailed description
IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.
To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain. Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed.
Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine-Prilocaine cream | Active comparator | Drug: lidocaine-Prilocaine creamlidocaine-Prilocaine anesthetic cream placed into their cervix prior to having the IUD inserted |
| placebo cream | Placebo comparator | Drug: placebo creaman inert placebo cream placed into their cervix |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- Women not taken misoprostol prior to IUD insertion
- No contraindication to or history of allergic reaction to lidocaine
- Women who will accept to participate in the study
Key exclusion criteria (2 listed)
- Lidocaine allergy
- Any contraindication to IUD placement
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-Prilocaine cream | Drug | lidocaine-Prilocaine cream |
| placebo cream | Drug | placebo cream |
Primary outcome
Mean pain score during IUD insertion
Time frame: 5 minutes
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 9 Aug 2016.
Related trials for IUD Pain
Enrolling by invitationPhase 2
Oral Ketorolac for IUD Pain Reduction
IUD Insertion Pain
Recruiting
Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
IUD, Abnormal Uterine Bleeding
Recruiting
Development of a Pain Control Options Menu for IUD Insertion
IUD Insertion Pain
Recruiting
TENS Unit for Analgesia During IUD Insertion
IUD, Analgesia
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 Phase 2 study testing lidocaine-Prilocaine cream in people with IUD Pain, run by Assiut University at 1 site in Egypt.
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 4 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 9 Aug 2016. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean pain score during IUD insertion (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.