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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01303614
Acronym
HSG-2010
Enrollment
100
Registered
2011-02-25
Start date
2011-04-30
Completion date
2012-09-30
Last updated
2011-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Pathology

Keywords

hysterosalpingography, prilocaine, local anaesthetic, pain relief, gynecological pathology

Brief summary

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

Interventions

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.

DRUGplacebo

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.

Sponsors

Consorci Sanitari de Terrassa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain reduction in the performance of hysterosalpingographyafter hysterosalpingography and a month laterdecrease in pain inmediately after the completion of hysterosalpingography and one month after completion of the diagnostic test by an analogue pain scale.

Secondary

MeasureTime frameDescription
sense of discomfort experience during the procedurea month after hysterosalpingographywillingness to repeat the diagnostic technique

Countries

Spain

Contacts

Primary ContactBaldomero Arnau Rivera, MD, PhD
barnau@cst.cat0034 937314138

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026