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

April 8, 2010 updated by: Consorci Sanitari de Terrassa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after hysteroscopy and a month later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sense of discomfort experience during the procedure
Time Frame: a month after hysteroscopy
willingness to repeat the diagnostic technique
a month after hysteroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Baldomero Arnau, MD, PhD, Consorci Sanitari de Terrassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 9, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HISTEROS-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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