Intracervical Lidocaine Gel for IUD Insertional Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Anne Davis, Columbia University
ClinicalTrials.gov Identifier:
NCT01214161
First received: September 29, 2010
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Pain
Drug: 2% lidocaine gel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • pain during IUD insertion [ Time Frame: 10 minutes after IUD insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events such as failed insertion [ Time Frame: 10 minutes after IUD insertion ] [ Designated as safety issue: No ]
  • provider's assessment of patient's pain on a visual analogue scale [ Time Frame: 10 minutes after IUD insertion ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine gel
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
Drug: 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.

Other Names:
  • Surgilube
  • Fougera lidocaine gel
Placebo Comparator: placebo gel (surgilube)
This group will be randomized to having the intervention with the placebo surgilube gel.
Drug: 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.

Other Names:
  • Surgilube
  • Fougera lidocaine gel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  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: NCT01214161

Locations
United States, New York
Family Planning Clinic
New York, New York, United States, 10032
Family Planning Practice
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Anne Davis, MD Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Davis, Associate Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT01214161     History of Changes
Other Study ID Numbers: AAAE9330
Study First Received: September 29, 2010
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014