Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice (HSG-2010)
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|ClinicalTrials.gov Identifier: NCT01303614|
Recruitment Status : Unknown
Verified September 2010 by Consorci Sanitari de Terrassa.
Recruitment status was: Not yet recruiting
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gynecological Pathology||Drug: Lidocaine-Prilocaine cream Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||September 2012|
|Active Comparator: Lidocaine-Prilocaine cream||
Drug: Lidocaine-Prilocaine cream
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.
Other Name: EMLA
Placebo Comparator: Placebo
purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
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.
- 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.
- sense of discomfort experience during the procedure [ Time Frame: a month after hysterosalpingography ]willingness to repeat the diagnostic technique
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303614
|Contact: Baldomero Arnau Rivera, MD, PhD||0034 email@example.com|
|Consorci Sanitari de Terrassa|
|Terrassa, Barcelona, Spain, 08227|
|Contact: Baldomero Arnau Rivera 0034 937314138 firstname.lastname@example.org|
|Principal Investigator: Baldomero Arnau Rivera, MD, PhD|
|Principal Investigator:||Baldomero Arnau Rivera, MD, PhD||Consorci Sanitari de Terrassa|