Brief Summary

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Official Title: "Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial"

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

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Study Primary Completion Date: April 2012

Interventions Used in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Lidocaine-Prilocaine cream
• Placebo Comparator: Placebo
  • purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid

Outcome Measures for this Clinical Trial

Primary Measures

• pain reduction in the performance of hysterosalpingography
  • Time Frame: after hysterosalpingography and a month later
    Safety Issue?: No

Secondary Measures

• sense of discomfort experience during the procedure
  • Time Frame: a month after hysterosalpingography
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Consorci Sanitari de Terrassa
• Provider of Information About this Clinical Study
  • Baldomero Arnau Rivera, Consorci Sanitari de Terrassa
• Overall Official(s)
  • Baldomero Arnau Rivera, MD, PhD, Principal Investigator, Consorci Sanitari de Terrassa
• Overall Contact(s)
  • Baldomero Arnau Rivera, MD, PhD, 0034 937314138, barnau@cst.cat