Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice (HSG-2010)

February 24, 2011 updated by: Consorci Sanitari de Terrassa

Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

  • Name: Baldomero Arnau Rivera, MD, PhD
  • Phone Number: 0034 937314138
  • Email: barnau@cst.cat

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa
        • Contact:
          • Baldomero Arnau Rivera
          • Phone Number: 0034 937314138
          • Email: barnau@cst.cat
        • Principal Investigator:
          • Baldomero Arnau Rivera, MD, PhD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after hysterosalpingography 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 hysterosalpingography
willingness to repeat the diagnostic technique
a month after hysterosalpingography

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 Rivera, MD, PhD, Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

February 25, 2011

Last Update Submitted That Met QC Criteria

February 24, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hysterosalpingography-2010

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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