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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
Sponsor:
Information provided by:

Study Description
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

Study Design

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

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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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


Contacts
Contact: Baldomero Arnau Rivera, MD, PhD 0034 937314138 barnau@cst.cat

Locations
Spain
Consorci Sanitari de Terrassa Not yet recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Baldomero Arnau Rivera    0034 937314138    barnau@cst.cat   
Principal Investigator: Baldomero Arnau Rivera, MD, PhD         
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Investigators
Principal Investigator: Baldomero Arnau Rivera, MD, PhD Consorci Sanitari de Terrassa
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baldomero Arnau Rivera, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT01303614     History of Changes
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:
hysterosalpingography
prilocaine
local anaesthetic
pain relief
gynecological pathology

Additional relevant MeSH terms:
Lidocaine
Prilocaine
EMLA
Anesthetics, Local
Anesthetics
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