Gynecological Pathology Clinical Trial
— HSG-2010Official 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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Consorci Sanitari de Terrassa | Terrassa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Consorci Sanitari de Terrassa |
Spain,
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 |