Anesthetics, LocalPhase 2NCT02640183
EMLA Cream in Hysteroscopy Practice
A Phase 2 study testing EMLA in people with Anesthetics, Local, run by Ain Shams Maternity Hospital.
Trial summary
The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthetics, Local
- What is being tested?
- EMLA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that must perform a diagnostic hysteroscopy.
- Acceptance to participate in the study.
- Signed informed consent.
- Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
- Absence of sedative use 24 h before admission
Who cannot join
- Hypersensitivity or allergy to anesthetics
- refusal of the patient
- Patients under age 18 and pregnant.
- Patients on anti-arrhythmic drugs due to possibility of drug interaction.
- Unbearable pain that involves other analgesic measures.
- Allergic reactions to topical anesthetics
About this study
Official title: Lidocaine-Prilocaine (EMLA®) Cream in Hysteroscopy Practice: A Prospective Randomized Non-blinded Controlled Study
The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.
- Conditions
- Anesthetics, Local
- Being tested
- EMLA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLADrug
PlaceboOther
Also called Ultrasound gel
| Study group | Role | What they receive |
|---|---|---|
| Group A (EMLA) | Experimental | 3 mL EMLA® cream 5% will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn. Receives: Drug: EMLA |
| Group B (Placebo) | Placebo comparator | 3 mL of ultrasonic gel will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experienced during the procedure scored using a VAS.
All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure.
After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, LocalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640183
- Sponsor's protocol ID
- EMLA-Hsc
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine-Prilocaine (EMLA®) Cream in Hysteroscopy Practice: A Prospective Randomized Non-blinded Controlled Study
- ClinicalTrials.gov ID
- NCT02640183
- Acronym / sponsor ID
- EMLA-Hsc
- Conditions
- Anesthetics, Local
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 28 Dec 2015 (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 aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (EMLA) | Experimental | Drug: EMLA3 mL EMLA® cream 5% will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn. |
| Group B (Placebo) | Placebo comparator | Other: Placebo3 mL of ultrasonic gel will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients that must perform a diagnostic hysteroscopy.
- Acceptance to participate in the study.
- Signed informed consent.
- Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
- Absence of sedative use 24 h before admission
Key exclusion criteria (6 listed)
- Hypersensitivity or allergy to anesthetics
- refusal of the patient
- Patients under age 18 and pregnant.
- Patients on anti-arrhythmic drugs due to possibility of drug interaction.
- Unbearable pain that involves other analgesic measures.
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 |
|---|---|---|
| EMLA | Drug | Group A (EMLA) |
| PlaceboAlso: Ultrasound gel | Other | Group B (Placebo) |
Primary outcome
Pain experienced during the procedure scored using a VAS.
Time frame: Procedure
All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure. After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMLA in people with Anesthetics, Local, run by Ain Shams Maternity Hospital.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 experienced during the procedure scored using a VAS. (time frame: Procedure). 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 28 Dec 2015.