Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

December 20, 2011 updated by: Mohamed Saied Eldin Elsafty, Ain Shams University
The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohamed S.Eldin Elsafty, Lecturer
  • Phone Number: +201003922211
  • Email: emeira2@gmail.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospital
        • Contact:
          • Mohamed Ibrahim Emeira, Lecturer
          • Phone Number: +201224456471
          • Email: emeira2@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18-45
  • Speak Arabic or English

Exclusion Criteria:

  • History of cervical surgery
  • Known hypersensitivity to topical analgesics
  • First trimester abortion or miscarriage in the previous six weeks
  • Second trimester abortion or miscarriage in the previous 12 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: saline
Active Comparator: lidocaine spray 10%
Drug: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS score of Pain
Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum)
5 minutes from lidocaine spraying ( after application of tenaculum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ali elyan 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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