Overview

This trial is active, not recruiting.

Condition pain
Treatment 2% lidocaine gel
Sponsor Columbia University
Start date September 2010
End date March 2011
Trial size 200 participants
Trial identifier NCT01214161, AAAE9330

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose supportive care
Arm
(Experimental)
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel Surgilube
Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel. Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
(Placebo Comparator)
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel Surgilube
Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel. Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.

Primary Outcomes

Measure
pain during IUD insertion
time frame: 10 minutes after IUD insertion

Secondary Outcomes

Measure
adverse events such as failed insertion
time frame: 10 minutes after IUD insertion
provider's assessment of patient's pain on a visual analogue scale
time frame: 10 minutes after IUD insertion

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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 Exclusion Criteria: - Lidocaine allergy - First trimester abortion or miscarriage in the previous six weeks - Second trimester abortion or miscarriage in the previous 12 weeks

Additional Information

Official title Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial
Principal investigator Anne Davis, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Columbia University.