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

Gynecological Pathology Clinical Trial

— HSG-2010  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01303614
• Other study ID #: Hysterosalpingography-2010
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 24, 2011
• Last updated: February 24, 2011
• Start date: April 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2010
• Source: Consorci Sanitari de Terrassa
• Contact: Baldomero Arnau Rivera, MD, PhD
• Phone: 0034 937314138
• Email: barnau[@]cst.cat
• Is FDA regulated: No
• Health authority: SPAIN: Spanish Agency of the drug and medical device
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gynecological Pathology

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.
• 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.

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 hysterosalpingography	decrease in pain inmediately after the completion of hysterosalpingography and one month after completion of the diagnostic test by an analogue pain scale.	after hysterosalpingography and a month later	No
Secondary	sense of discomfort experience during the procedure	willingness to repeat the diagnostic technique	a month after hysterosalpingography	No