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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Consorci Sanitari de Terrassa.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT01303614
First received: February 24, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted

February 24, 2011
February 24, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
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
Female
18 Years to 80 Years
No
Contact: Baldomero Arnau Rivera, MD, PhD 0034 937314138 barnau@cst.cat
Spain
 
NCT01303614
Hysterosalpingography-2010
No
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