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

Sponsor
Consorci Sanitari de Terrassa (Other)
Overall Status
Completed
CT.gov ID
NCT01094015
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
21
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine-prilocaine cream
  • Other: gel application for the transmission of ultrasound
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
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
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Apr 1, 2009

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 Names:
  • 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 Names:
  • Transonic-Gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain reduction in the performance of hysteroscopy [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

    1. sense of discomfort experience during the procedure [a month after hysteroscopy]

      willingness to repeat the diagnostic technique

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01094015
    Other Study ID Numbers:
    • HISTEROS-07
    First Posted:
    Mar 26, 2010
    Last Update Posted:
    Apr 9, 2010
    Last Verified:
    Mar 1, 2006
    Keywords provided by , ,
    hysteroscopy
    local anaesthetic
    pain relief
    gynecological pathology
    Additional relevant MeSH terms:
    Lidocaine
    Prilocaine
    Lidocaine, Prilocaine Drug Combination

    Study Results

    No Results Posted as of Apr 9, 2010