PainPhase 4HISTEROS-07NCT01094015
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice
A Phase 4 study testing lidocaine-prilocaine cream and gel application for the transmission of ultrasound in people with Pain, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- lidocaine-prilocaine cream and gel application for the transmission of ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2007to Apr 2009
- Phase
- Phase 4
- 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 he must perform a diagnostic hysteroscopy
- acceptance to participate in the study signed informed consent
Who cannot join
- hypersensitivity or allergy to anesthetics
- refusal of the patient
- patients under age 18 and pregnant
- dropout
- unbearable pain that involves other analgesic measures
- allergic reactions to topical anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.
- Conditions
- Pain
- Being tested
- lidocaine-prilocaine cream, gel application for the transmission of ultrasound
- Keywords
- hysteroscopy, local anaesthetic, pain relief, gynecological pathology
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-prilocaine creamDrug
Also called EMLA
Implementation of 3 cm of lidocaine-prilocaine in the endocervical canal, 10 minutes before the intervention with a syringe without needle 5ml. Application, with a swab of the anesthetic cream ectocervix level.
gel application for the transmission of ultrasoundOther
Also called Transonic-Gel
3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5ml syringe without needle. Application, with a swab in gel ectocervix
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-Prilocaine cream | Active comparator | Not described Receives: Drug: lidocaine-prilocaine cream |
| placebo | Placebo comparator | Not described Receives: Other: gel application for the transmission of ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction in the performance of hysteroscopy
decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale
Measured: after hysteroscopy and a month later
Secondary outcomes (1)
sense of discomfort experience during the procedure
willingness to repeat the diagnostic technique
Measured: a month after hysteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Investigators
- Baldomero Arnau, MD, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094015
- Sponsor's protocol ID
- HISTEROS-07
- Acronym
- HISTEROS-07
- Status last verified
- Mar 2006
- First submitted
- 23 Mar 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01094015
- Acronym / sponsor ID
- HISTEROS-07 / HISTEROS-07
- Conditions
- Pain
- Keywords
- hysteroscopy, local anaesthetic, pain relief, gynecological pathology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Mar 2010 (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 this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-Prilocaine cream | Active comparator | Drug: lidocaine-prilocaine cream |
| placebo | Placebo comparator | Other: gel application for the transmission of ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients that he must perform a diagnostic hysteroscopy
- acceptance to participate in the study signed informed consent
Key exclusion criteria (6 listed)
- hypersensitivity or allergy to anesthetics
- refusal of the patient
- patients under age 18 and pregnant
- dropout
- 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 |
|---|---|---|
| lidocaine-prilocaine creamAlso: EMLAImplementation of 3 cm of lidocaine-prilocaine in the endocervical canal, 10 minutes before the intervention with a syringe without needle 5ml. Application, with a swab of the anesthetic cream ectocervix level. | Drug | Lidocaine-Prilocaine cream |
| gel application for the transmission of ultrasoundAlso: Transonic-Gel3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5ml syringe without needle. Application, with a swab in gel ectocervix | Other | placebo |
Primary outcome
pain reduction in the performance of hysteroscopy
Time frame: after hysteroscopy and a month later
decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale
1 secondary outcome
sense of discomfort experience during the procedure
Time frame: a month after hysteroscopy
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 Apr 2010.
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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.
Baldomero Arnau, MD, PhD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine-prilocaine cream and gel application for the transmission of ultrasound in people with Pain, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 9 Apr 2010. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pain reduction in the performance of hysteroscopy (time frame: after hysteroscopy and a month later). 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 Apr 2010.