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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Mohamed Saied Eldin Elsafty, Ain Shams University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Mohamed Saied Eldin Elsafty, Ain Shams University Identifier:
First received: December 13, 2011
Last updated: December 20, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Drug Usage Drug: Lidocaine Drug: saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Mohamed Saied Eldin Elsafty, Ain Shams University:

Primary Outcome Measures:
  • VAS score of Pain [ Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum) ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lidocaine spray 10% Drug: Lidocaine
Placebo Comparator: Saline Drug: saline


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01496105

Contact: Mohamed S.Eldin Elsafty, Lecturer +201003922211

Ain shams university hospital Recruiting
Cairo, Egypt
Contact: Mohamed Ibrahim Emeira, Lecturer    +201224456471   
Sponsors and Collaborators
Ain Shams University
  More Information

Responsible Party: Mohamed Saied Eldin Elsafty, Lecturer of Obstetrics and Gynecology, Ain Shams University Identifier: NCT01496105     History of Changes
Other Study ID Numbers: ali elyan 2011
Study First Received: December 13, 2011
Last Updated: December 20, 2011

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017