A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion

NCT ID: NCT01292447

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-02-28

Brief Summary

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.

Conditions

Pain

Study Design

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

Study Groups

Control Group

Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DRUG

Inert gel x 1

Study Group

Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.

Group Type: EXPERIMENTAL

2% lidocaine gel

Intervention Type: DRUG

120mg lidocaine x 1

Interventions

2% lidocaine gel

120mg lidocaine x 1

Intervention Type: DRUG

Placebo gel

Inert gel x 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. plans for IUD insertion for contraception or abnormal uterine bleeding;

2. 18 to 49 years of age;

3. reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;

4. no prior IUD use;

5. not taken analgesics or anxiolytics in the previous 24 hours;

6. not taken misoprostol prior to IUD insertion;

7. the ability and are willing to give informed consent;

8. speaks English or Spanish.

Exclusion Criteria

1. any contraindication to IUD placement;

2. allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;

3. chronic narcotic/benzodiazepine/barbiturate use within the past year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Rebecca H. Allen, MD

Assistant Professor ob/gyn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca H Allen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital of Rhode Island

Locations

Women's Primary Care Center/Women and Infants' Hospital

Providence, Rhode Island, United States

Womens Primary Care Center

Providence, Rhode Island, United States

Countries

United States

References

Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.

Reference Type: DERIVED

PMID: 24012096 (View on PubMed)

Other Identifiers

10-0084

Identifier Type: -

Identifier Source: org_study_id