Intracervical Lidocaine Gel for IUD Insertional Pain

NCT01214161 | Completed Results

• 1 other identifier: AAAE9330
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

IUD; Lidocaine gel

Outcome Measures

Primary Outcomes (1)

• Pain During IUD Insertion at Various Time Points (See Description for Time Points)

  Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.

  During IUD insertion (see above description for which time points)

Secondary Outcomes (2)

• Adverse Events

  During IUD insertion

• Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale

  during IUD insertion

Study Arms (2)

lidocaine gel

EXPERIMENTAL

This group will be those randomized to receiving the intervention with 2% lidocaine gel.

Drug: 2% lidocaine gel

placebo gel (surgilube)

PLACEBO COMPARATOR

This group will be randomized to having the intervention with the placebo surgilube gel.

Other: placebo

Interventions

2% lidocaine gel DRUG

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.

lidocaine gel

placebo OTHER

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/placebo 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.

Also known as: surgilube

placebo gel (surgilube)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Lidocaine allergy
• First trimester abortion or miscarriage in the previous six weeks
• Second trimester abortion or miscarriage in the previous 12 weeks

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Family Planning Clinic / Columbia University Family Planning Practice

New York, New York, 10032, United States

Location

Related Publications (1)

• Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.

  PMID: 22325115 DERIVED

MeSH Terms

Conditions

Pain

Interventions

phenylmercury borate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne Davis, MD
• Organization: Columbia University

ard4@cumc.columbia.edu

212-305-4951

Study Officials

• Anne Davis, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 4, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2013
• Last Updated: April 7, 2016
• Results First Posted: April 7, 2016

Record last verified: 2016-03

Locations

US (1)