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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

Brief Summary:
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.

Condition or disease Intervention/treatment Phase
Gynecological Pathology Drug: Lidocaine-Prilocaine cream Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. sense of discomfort experience during the procedure [ Time Frame: a month after hysterosalpingography ]
    willingness to repeat the diagnostic technique

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01303614

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Contact: Baldomero Arnau Rivera, MD, PhD 0034 937314138

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Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Contact: Baldomero Arnau Rivera    0034 937314138   
Principal Investigator: Baldomero Arnau Rivera, MD, PhD         
Sponsors and Collaborators
Consorci Sanitari de Terrassa
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Principal Investigator: Baldomero Arnau Rivera, MD, PhD Consorci Sanitari de Terrassa
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Baldomero Arnau Rivera, Consorci Sanitari de Terrassa Identifier: NCT01303614    
Other Study ID Numbers: Hysterosalpingography-2010
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: September 2010
Keywords provided by Consorci Sanitari de Terrassa:
local anaesthetic
pain relief
gynecological pathology
Additional relevant MeSH terms:
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Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined