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

Phase 4
Conditions
Gynecological Pathology
Interventions
Drug: Lidocaine-Prilocaine cream
Drug: placebo
Registration Number
NCT01303614
Lead Sponsor
Consorci Sanitari de Terrassa
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lidocaine-Prilocaine creamLidocaine-Prilocaine cream-
Placeboplacebopurified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
Primary Outcome Measures
NameTimeMethod
pain reduction in the performance of hysterosalpingographyafter hysterosalpingography and a month later

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
NameTimeMethod
sense of discomfort experience during the procedurea month after hysterosalpingography

willingness to repeat the diagnostic technique

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa

🇪🇸

Terrassa, Barcelona, Spain

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