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

NCT ID: NCT01094015

Last Updated: 2010-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lidocaine-Prilocaine cream

Group Type ACTIVE_COMPARATOR

lidocaine-prilocaine cream

Intervention Type DRUG

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.

placebo

Group Type PLACEBO_COMPARATOR

gel application for the transmission of ultrasound

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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EMLA Transonic-Gel

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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


* dropout
* unbearable pain that involves other analgesic measures
* allergic reactions to topical anesthetics
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Department of Gynecology

Principal Investigators

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Baldomero Arnau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Locations

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Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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HISTEROS-07

Identifier Type: -

Identifier Source: org_study_id

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