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NCT01094015 Clinical Trial

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

Pain Clinical Trial

— HISTEROS-07  

Official title:
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01094015
Other study ID # HISTEROS-07
Secondary ID
Status Completed
Phase Phase 4
First received March 23, 2010
Last updated April 8, 2010
Start date July 2007
Est. completion date April 2009

Study information
Verified date March 2006
Source Consorci Sanitari de Terrassa
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date April 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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:
• 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

Locations
Country Name City State
Spain Consorci Sanitari de Terrassa Terrassa Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain reduction in the performance of hysteroscopy decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale after hysteroscopy and a month later No
Secondary sense of discomfort experience during the procedure willingness to repeat the diagnostic technique a month after hysteroscopy No
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