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Completed

NCT Number: NCT01094015

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

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

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine-prilocaine cream

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.

Other names: EMLA

gel application for the transmission of ultrasound

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

Other names: Transonic-Gel

Primary outcomes

  1. 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

Secondary outcomes

  1. sense of discomfort experience during the procedure

    Time frame: a month after hysteroscopy

    willingness to repeat the diagnostic technique

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial

Acronym: HISTEROS-07

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 26, 2010
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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