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

NCT01445756 | Completed Early Phase 1

• 1 other identifier: H-2010-0062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Intrauterine Device

Outcome Measures

Primary Outcomes (1)

• Change in pain level from no Lidocaine administered to after Lidocaine is administered

  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.

  Pain assessments prior to procedure, immediately after procedure, and 10 minutes after the procedure

Study Arms (2)

Topical Lidocaine

ACTIVE COMPARATOR

Topical Lidocaine

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lidocaine DRUG

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.

Topical Lidocaine

Placebo DRUG

Placebo; no topical lidocaine administered

Also known as: No intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be at least 18 years old

You may not qualify if:

• Age \<18
• Non-English speaking
• Illiterate
• History of pregnancy with delivery \>20 weeks
• History of prior IUD insertion or attempt

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University Health Services Women's Care Clinic

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mary Landry, MD

  University of Wisconsin Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: October 4, 2011
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

US (1)