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

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ClinicalTrials.gov Identifier: NCT01292447
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : December 10, 2013
Society of Family Planning
Information provided by (Responsible Party):
Vinita Goyal, Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment
Pain Drug: 2% lidocaine gel Drug: Placebo gel

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion
Study Start Date : February 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control Group
Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Drug: Placebo gel
Inert gel x 1
Experimental: Study Group
Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
Drug: 2% lidocaine gel
120mg lidocaine x 1

Primary Outcome Measures :
  1. Mean pain score during IUD insertion [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Lidocaine side effects [ Time Frame: Day 1 ]
  2. Time for IUD insertion [ Time Frame: Day 1 ]
  3. Insertion difficulty as rated by the clinician [ Time Frame: Day 1 ]
  4. Insertion complications [ Time Frame: Day 1 and 6 weeks after IUD insertion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292447

United States, Rhode Island
Women's Primary Care Center/Women and Infants' Hospital
Providence, Rhode Island, United States, 02905
Womens Primary Care Center
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Society of Family Planning
Principal Investigator: Rebecca H Allen, MD, MPH Women and Infants Hospital of Rhode Island

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vinita Goyal, Assistant Professor ob/gyn, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01292447     History of Changes
Other Study ID Numbers: 10-0084
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Vinita Goyal, Women and Infants Hospital of Rhode Island:
Pain measurement
Intrauterine devices

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action