Gynecological PathologyPhase 4HSG-2010NCT01303614
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice
A Phase 4 study testing Lidocaine-Prilocaine cream in people with Gynecological Pathology, 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 hysterosalpingography diagnostic practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecological Pathology
- What is being tested?
- Lidocaine-Prilocaine cream
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Sep 2012
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients that must perform a hysterosalpingography
- 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 years old and pregnant
- unbearable pain that involves other analgesic measures
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Baldomero Arnau Rivera, 0034 937314138, barnau@cst.cat
Baldomero Arnau Rivera, MD, PhD
About this study
Official title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.
- Conditions
- Gynecological Pathology
- Being tested
- Lidocaine-Prilocaine cream, placebo
- Keywords
- hysterosalpingography, prilocaine, local anaesthetic, pain relief, gynecological pathology
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.
placeboDrug
3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5 ml 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 | purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction in the performance of hysterosalpingography
decrease in pain inmediately after the completion of hysterosalpingography and one month after completion of the diagnostic test by an analogue pain scale.
Measured: after hysterosalpingography and a month later
Secondary outcomes (1)
sense of discomfort experience during the procedure
willingness to repeat the diagnostic technique
Measured: a month after hysterosalpingography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionSep 2012 (estimated)
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 Gynecological PathologyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Investigators
- Baldomero Arnau Rivera, MD, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303614
- Sponsor's protocol ID
- Hysterosalpingography-2010
- Acronym
- HSG-2010
- Status last verified
- Sep 2010
- First submitted
- 24 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnau B, Jovell E, Romero M, Gonzalez M, Esteba L, Garcia A. Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.
PubMed 25445103
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01303614
- Acronym / sponsor ID
- HSG-2010 / Hysterosalpingography-2010
- Conditions
- Gynecological Pathology
- Keywords
- hysterosalpingography, prilocaine, local anaesthetic, pain relief, gynecological pathology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 25 Feb 2011 (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 hysterosalpingography diagnostic practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-Prilocaine cream | Active comparator | Drug: Lidocaine-Prilocaine cream |
| Placebo | Placebo comparator | Drug: placebopurified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients that must perform a hysterosalpingography
- acceptance to participate in the study signed informed consent
Key exclusion criteria (4 listed)
- hypersensitivity or allergy to anesthetics
- refusal of the patient
- patients under age 18 years old and pregnant
- 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 |
| placebo3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5 ml syringe without needle. Application, with a swab in gel ectocervix. | Drug | Placebo |
Primary outcome
pain reduction in the performance of hysterosalpingography
Time frame: after hysterosalpingography and a month later
decrease in pain inmediately after the completion of hysterosalpingography 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 hysterosalpingography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
- Derived from this study: PubMed 25445103Arnau B, Jovell E, Romero M, Gonzalez M, Esteba L, Garcia A. Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.
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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 Rivera, 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 in people with Gynecological Pathology, 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 4 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 25 Feb 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baldomero Arnau Rivera, MD, PhD (0034 937314138, barnau@cst.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain reduction in the performance of hysterosalpingography (time frame: after hysterosalpingography and a month later). 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 NCT01303614, 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 Feb 2011.