NCT01094015

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Jul 2007

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
Last Updated

April 9, 2010

Status Verified

March 1, 2006

Enrollment Period

1.5 years

First QC Date

March 23, 2010

Last Update Submit

April 8, 2010

Conditions

Pain

Keywords

hysteroscopylocal anaestheticpain reliefgynecological pathology

Outcome Measures

Primary Outcomes (1)

  • pain reduction in the performance of hysteroscopy

    decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale

    after hysteroscopy and a month later

Secondary Outcomes (1)

  • sense of discomfort experience during the procedure

    a month after hysteroscopy

Study Arms (2)

Lidocaine-Prilocaine cream

ACTIVE COMPARATOR
Drug: lidocaine-prilocaine cream

placebo

PLACEBO COMPARATOR
Other: gel application for the transmission of ultrasound

Interventions

lidocaine-prilocaine creamDRUG

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.

Also known as: EMLA
Lidocaine-Prilocaine cream
gel application for the transmission of ultrasoundOTHER

3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5ml syringe without needle. Application, with a swab in gel ectocervix

Also known as: Transonic-Gel
placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients that he must perform a diagnostic hysteroscopy
  • 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 and pregnant
  • dropout
  • unbearable pain that involves other analgesic measures
  • allergic reactions to topical anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Baldomero Arnau, MD, PhD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 26, 2010

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

April 9, 2010

Record last verified: 2006-03

Locations

ES(1)