Cervical Lidocaine for Intrauterine Device Insertion Pain (CLIIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01411995
First received: August 3, 2011
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before IUD insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.


Condition Intervention
Pain
Intrauterine Device
Drug: 2% lidocaine gel
Drug: Water based lubricant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RCT of Cervical Lidocaine for Intrauterine Device Insertion Pain

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Pain score [ Time Frame: Immediately following insertion ] [ Designated as safety issue: No ]
    Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure.The entirety of teh procedure should last no more than 5-10 minuites. The pain score is assessed at the 3 timepoints within that 10 minuite window. No additional followup is required.


Enrollment: 200
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2% Lidocaine gel
Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal
Drug: 2% lidocaine gel
3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion
Placebo Comparator: Water based lubricant
Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal
Drug: Water based lubricant
3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-45 yrs
  • selecting intrauterine device contraception
  • able and willing to consent

Exclusion Criteria:

  • non-English speaking
  • current intrauterine device use
  • expulsion of intrauterine device within 2 weeks
  • allergy to lidocaine or water based lubricant
  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 ClinicalTrials.gov identifier: NCT01411995

Locations
United States, Missouri
Division of Clinical Research at Washington University
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01411995     History of Changes
Other Study ID Numbers: 201105067
Study First Received: August 3, 2011
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
intrauterine device
pain
lidocaine gel

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014