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Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion

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ClinicalTrials.gov Identifier: NCT01445756
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

August 23, 2011
October 4, 2011
August 26, 2014
July 2010
June 2011   (Final data collection date for primary outcome measure)
Change in pain level from no Lidocaine administered to after Lidocaine is administered [ Time Frame: Pain assessments prior to procedure, immediately after procedure, and 10 minutes after the procedure ]
The investigators plan to engage 40 patients in this study, and will ask each to fill out a questionnaire that covers age, ethnicity, pregnancy history, reason for IUD insertion and recent medication use. Patients will be asked to assess their pain on 3 separate occasions during the visit, by marking an X on a Visual Analog Scale. Providers will also be asked to fill out a questionnaire covering their experience with the interventions as well as their assessment of the patients' pain during the procedures.
Same as current
Complete list of historical versions of study NCT01445756 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion
Topical Lidocaine for Pain Control With IUD Insertion: A Randomized Controlled Trial
Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.
The investigators research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Pain
  • Drug: Lidocaine
    During the procedure (placement of the IUD), 1ml of gel will be applied to the anterior lip of the cervix. After 1 minute of waiting, a tenaculum will be placed to steady the cervix. The catheter will be introduced into the cervical canal, past the external os and 1-1.5ml of gel will be placed into the canal. After another minute, the IUD will be placed in the standard fashion.
  • Drug: Placebo
    Placebo; no topical lidocaine administered
    Other Name: No intervention
  • Active Comparator: Topical Lidocaine
    Topical Lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be at least 18 years old

Exclusion Criteria:

  • Age <18
  • Non-English speaking
  • Illiterate
  • History of pregnancy with delivery >20 weeks
  • History of prior IUD insertion or attempt
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01445756
H-2010-0062
No
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Mary Landry, MD University of Wisconsin Health Services
University of Wisconsin, Madison
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP