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

NCT ID: NCT01303614

Last Updated: 2011-02-25

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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Conditions

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Gynecological Pathology

Keywords

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hysterosalpingography prilocaine local anaesthetic pain relief gynecological pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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

purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

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

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.

Intervention Type DRUG

Other Intervention Names

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EMLA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Consorci Sanitari de Terrassa

Principal Investigators

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Baldomero Arnau Rivera, 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

Central Contacts

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Baldomero Arnau Rivera, MD, PhD

Role: CONTACT

Phone: 0034 937314138

Email: [email protected]

Facility Contacts

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Baldomero Arnau Rivera

Role: primary

References

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Arnau B, Jovell E, Romero M, Gonzalez M, Esteba L, Garcia A. Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.

Reference Type DERIVED
PMID: 25445103 (View on PubMed)

Other Identifiers

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Hysterosalpingography-2010

Identifier Type: -

Identifier Source: org_study_id