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

This study has been completed.
Sponsor:
Information provided by:
Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT01094015
First received: March 23, 2010
Last updated: April 8, 2010
Last verified: March 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
 Drug: lidocaine-prilocaine cream
Other: gel application for the transmission of ultrasound
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Consorci Sanitari de Terrassa:

Primary Outcome Measures:
  • pain reduction in the performance of hysteroscopy [ Time Frame: after hysteroscopy and a month later ] [ Designated as safety issue: No ]
    decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale


Secondary Outcome Measures:
  • sense of discomfort experience during the procedure [ Time Frame: a month after hysteroscopy ] [ Designated as safety issue: No ]
    willingness to repeat the diagnostic technique


Enrollment: 92
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EMLA
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 Name: Transonic-Gel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094015

Locations
Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Investigators
Principal Investigator: Baldomero Arnau, MD, PhD Consorci Sanitari de Terrassa
  More Information

No publications provided

Responsible Party: Baldomero Arnau Rivera, Department of Gynecology
ClinicalTrials.gov Identifier: NCT01094015     History of Changes
Other Study ID Numbers: HISTEROS-07
Study First Received: March 23, 2010
Last Updated: April 8, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Consorci Sanitari de Terrassa:
hysteroscopy
local anaesthetic
pain relief
gynecological pathology

Additional relevant MeSH terms:
Anesthetics
Prilocaine
Lidocaine
EMLA
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Combined

ClinicalTrials.gov processed this record on May 23, 2013