Intracervical Lidocaine Gel for IUD Insertional Pain

NCT ID: NCT01214161

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

lidocaine gel

This group will be those randomized to receiving the intervention with 2% lidocaine gel.

Group Type: EXPERIMENTAL

2% lidocaine gel

Intervention Type: DRUG

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 gel (surgilube)

This group will be randomized to having the intervention with the placebo surgilube gel.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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/placebo 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.

Interventions

2% lidocaine gel

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.

Intervention Type: DRUG

placebo

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/placebo 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.

Intervention Type: OTHER

Other Intervention Names

surgilube

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Anne Davis

Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Family Planning Clinic / Columbia University Family Planning Practice

New York, New York, United States

Countries

United States

References

Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.

Reference Type: DERIVED

PMID: 22325115 (View on PubMed)

Other Identifiers

AAAE9330

Identifier Type: -

Identifier Source: org_study_id