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

This study has been completed.
Sponsor:
Information provided by:
Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT01094015
First received: March 23, 2010
Last updated: April 8, 2010
Last verified: March 2006
History of Changes

March 23, 2010
April 8, 2010
July 2007
January 2009   (final data collection date for primary outcome measure)
pain reduction in the performance of hysteroscopy [ Time Frame: after hysteroscopy and a month later ] [ Designated as safety issue: No ]
decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale
Same as current
Complete list of historical versions of study NCT01094015 on ClinicalTrials.gov Archive Site
sense of discomfort experience during the procedure [ Time Frame: a month after hysteroscopy ] [ 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 Hysteroscopy Practice
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial

The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • 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
  • 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
  • Active Comparator: Lidocaine-Prilocaine cream
    Intervention: Drug: lidocaine-prilocaine cream
  • Placebo Comparator: placebo
    Intervention: Other: gel application for the transmission of ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
April 2009
January 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01094015
HISTEROS-07
Yes
Baldomero Arnau Rivera, Department of Gynecology
Consorci Sanitari de Terrassa
Not Provided
Principal Investigator: Baldomero Arnau, MD, PhD Consorci Sanitari de Terrassa
Consorci Sanitari de Terrassa
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP