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

This study has been completed.
Society of Family Planning
Information provided by (Responsible Party):
Vinita Goyal, Women and Infants Hospital of Rhode Island Identifier:
First received: January 24, 2011
Last updated: December 6, 2013
Last verified: December 2013
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 Intervention
Drug: 2% lidocaine gel
Drug: Placebo gel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion

Resource links provided by NLM:

Further study details as provided by Vinita Goyal, Women and Infants Hospital of Rhode Island:

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

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

Enrollment: 150
Study Start Date: February 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vinita Goyal, Assistant Professor ob/gyn, Women and Infants Hospital of Rhode Island Identifier: NCT01292447     History of Changes
Other Study ID Numbers: 10-0084
Study First Received: January 24, 2011
Last Updated: December 6, 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 processed this record on May 25, 2017