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

Consorci Sanitari de Terrassa

Status and phase: Unknown; Phase 4

Conditions: Gynecological Pathology

Treatments: Drug: Lidocaine-Prilocaine cream; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01303614

Hysterosalpingography-2010

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Lidocaine-Prilocaine cream

Active Comparator group

Treatment:

Drug: Lidocaine-Prilocaine cream

Placebo

Placebo Comparator group

Description:

purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid

Treatment:

Drug: placebo