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Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice (HSG-2010)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Consorci Sanitari de Terrassa.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT01303614
First received: February 24, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Gynecological Pathology
Drug: Lidocaine-Prilocaine cream
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled 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 hysterosalpingography [ Time Frame: after hysterosalpingography and a month later ] [ Designated as safety issue: No ]
    decrease in pain inmediately after the completion of hysterosalpingography 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 hysterosalpingography ] [ Designated as safety issue: No ]
    willingness to repeat the diagnostic technique


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (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
purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01303614

Contacts
Contact: Baldomero Arnau Rivera, MD, PhD 0034 937314138 barnau@cst.cat

Locations
Spain
Consorci Sanitari de Terrassa Not yet recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Baldomero Arnau Rivera    0034 937314138    barnau@cst.cat   
Principal Investigator: Baldomero Arnau Rivera, MD, PhD         
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Investigators
Principal Investigator: Baldomero Arnau Rivera, MD, PhD Consorci Sanitari de Terrassa
  More Information

No publications provided

Responsible Party: Baldomero Arnau Rivera, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT01303614     History of Changes
Other Study ID Numbers: Hysterosalpingography-2010
Study First Received: February 24, 2011
Last Updated: February 24, 2011
Health Authority: SPAIN: Spanish Agency of the drug and medical device

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

Additional relevant MeSH terms:
EMLA
Lidocaine
Prilocaine
Anesthetics
Anesthetics, Combined
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014