Intracervical Lidocaine Gel for IUD Insertional Pain

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: 2% lidocaine gel; Other: placebo

• Registration Number: NCT01214161
• Lead Sponsor: Columbia University

Brief Summary

The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain

Detailed Description

The intrauterine device (IUD) is a highly effective, long-acting, reversible method of contraception used by approximately 8% of women in the developed world. In the United States, historically candidates for IUDs were monogamous, parous women. Recent research has shown that both copper and levonorgestrel IUD use is safe and effective in nulliparous women. Nulliparous and parous women can experience significant amounts of pain during IUD insertion. Concerns about insertional pain could be a barrier to IUD initiation women and their healthcare providers.

This study will recruit women at either the Family Planning Clinic or the offices of Columbia University Family Planning Practice who desire the copper or levonorgestrel IUD for birth control. Women who consent to participating in the study will be randomized to two groups: one group will receive 2% lidocaine gel placed in the cervix prior to IUD placement and the other group will receive a placebo inert gel. The primary objective of this study is to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring of the uterus) and at speculum removal; these are standard procedures during IUD insertion. Secondary outcomes include provider assessment of the patient's pain, patient's level of satisfaction with the insertion, and whether any adverse events such as nausea/vomiting, fainting, or IUD insertion failure occurred.

Study Timeline

• Study First Submitted: 2010-09-29
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2011-03
• Study Completion: 2013-06
• Results First Submitted: 2015-09-29
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-08
• Last Update Submitted: 2016-03-08
• Results First Posted: 2016-04-07
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Self-select either a Paragard or Mirena IUD and are appropriate for insertion as determined by their provider
• Age 18-45
• Speak English or Spanish

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Exclusion Criteria

• Lidocaine allergy
• First trimester abortion or miscarriage in the previous six weeks
• Second trimester abortion or miscarriage in the previous 12 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine gel	2% lidocaine gel	This group will be those randomized to receiving the intervention with 2% lidocaine gel.
placebo gel (surgilube)	placebo	This group will be randomized to having the intervention with the placebo surgilube gel.

Primary Outcome Measures

Name	Time	Method
Pain During IUD Insertion at Various Time Points (See Description for Time Points)	During IUD insertion (see above description for which time points)	Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	During IUD insertion
Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale	during IUD insertion	This secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.

Trial Locations

Locations (1)

Family Planning Clinic / Columbia University Family Planning Practice; 🇺🇸 New York, New York, United States