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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Vinita Goyal, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01292447
First received: January 24, 2011
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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
Pain
Drug: 2% lidocaine gel
Drug: Placebo gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Mean pain score during IUD insertion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lidocaine side effects [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Time for IUD insertion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Insertion difficulty as rated by the clinician [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Insertion complications [ Time Frame: Day 1 and 6 weeks after IUD insertion ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292447

Locations
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
Investigators
Principal Investigator: Rebecca H Allen, MD, MPH Women and Infants Hospital of Rhode Island
  More Information

No publications provided by Women and Infants Hospital of Rhode Island

Additional 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
Study First Received: January 24, 2011
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
Pain measurement
Intrauterine devices
Lidocaine

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

ClinicalTrials.gov processed this record on August 01, 2014