Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice (HSG-2010)
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303614
|Contact: Baldomero Arnau Rivera, MD, PhD||0034 firstname.lastname@example.org|
|Consorci Sanitari de Terrassa||Not yet recruiting|
|Terrassa, Barcelona, Spain, 08227|
|Contact: Baldomero Arnau Rivera 0034 937314138 email@example.com|
|Principal Investigator: Baldomero Arnau Rivera, MD, PhD|
|Principal Investigator:||Baldomero Arnau Rivera, MD, PhD||Consorci Sanitari de Terrassa|