Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice (HSG-2010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Consorci Sanitari de Terrassa

February 24, 2011
February 25, 2011
February 25, 2011
April 2011
April 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
sense of discomfort experience during the procedure [ Time Frame: a month after hysterosalpingography ]
willingness to repeat the diagnostic technique
Same as current
Not Provided
Not Provided
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Gynecological Pathology
  • 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
  • Drug: placebo
    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.
  • Active Comparator: Lidocaine-Prilocaine cream
    Intervention: Drug: Lidocaine-Prilocaine cream
  • Placebo Comparator: Placebo
    purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients that must perform a hysterosalpingography
  • acceptance to participate in the study signed informed consent

Exclusion Criteria:

  • hypersensitivity or allergy to anesthetics
  • refusal of the patient
  • patients under age 18 years old and pregnant
  • unbearable pain that involves other analgesic measures
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Baldomero Arnau Rivera, Consorci Sanitari de Terrassa
Consorci Sanitari de Terrassa
Not Provided
Principal Investigator: Baldomero Arnau Rivera, MD, PhD Consorci Sanitari de Terrassa
Consorci Sanitari de Terrassa
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP