Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice
HSG-2010
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFebruary 25, 2011
September 1, 2010
1 year
February 24, 2011
February 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
sense of discomfort experience during the procedure
a month after hysterosalpingography
Study Arms (2)
Lidocaine-Prilocaine cream
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORpurified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid
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.
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.
Eligibility Criteria
You may qualify if:
- patients that must perform a hysterosalpingography
- acceptance to participate in the study signed informed consent
You may not qualify if:
- hypersensitivity or allergy to anesthetics
- refusal of the patient
- patients under age 18 years old and pregnant
- unbearable pain that involves other analgesic measures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Related Publications (1)
Arnau B, Jovell E, Romero M, Gonzalez M, Esteba L, Garcia A. Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.
PMID: 25445103DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Baldomero Arnau Rivera, MD, PhD
Consorci Sanitari de Terrassa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
September 1, 2012
Last Updated
February 25, 2011
Record last verified: 2010-09