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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014