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Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice (HISTEROS-07)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094015
First Posted: March 26, 2010
Last Update Posted: April 9, 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.
Information provided by:
Consorci Sanitari de Terrassa
  Purpose
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.

Condition Intervention Phase
Pain Drug: lidocaine-prilocaine cream Other: gel application for the transmission of ultrasound Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Consorci Sanitari de Terrassa:

Primary Outcome Measures:
  • pain reduction in the performance of hysteroscopy [ Time Frame: after hysteroscopy and a month later ]
    decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale


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


Enrollment: 92
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Other: gel application for the transmission of ultrasound
3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5ml syringe without needle. Application, with a swab in gel ectocervix
Other Name: Transonic-Gel

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patients that he must perform a diagnostic hysteroscopy
  • acceptance to participate in the study signed informed consent

Exclusion Criteria prerandomization:

  • hypersensitivity or allergy to anesthetics
  • refusal of the patient
  • patients under age 18 and pregnant

Exclusion Criteria postrandomization:

  • dropout
  • unbearable pain that involves other analgesic measures
  • allergic reactions to topical anesthetics
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01094015


Locations
Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Investigators
Principal Investigator: Baldomero Arnau, MD, PhD Consorci Sanitari de Terrassa
  More Information

Responsible Party: Baldomero Arnau Rivera, Department of Gynecology
ClinicalTrials.gov Identifier: NCT01094015     History of Changes
Other Study ID Numbers: HISTEROS-07
First Submitted: March 23, 2010
First Posted: March 26, 2010
Last Update Posted: April 9, 2010
Last Verified: March 2006

Keywords provided by Consorci Sanitari de Terrassa:
hysteroscopy
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