NCT01292447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

January 24, 2011

Results QC Date

August 14, 2020

Last Update Submit

August 31, 2020

Conditions

Pain

Keywords

Pain measurementIntrauterine devicesLidocaine

Outcome Measures

Primary Outcomes (1)

  • Mean Pain Score During IUD Insertion

    0 to 100 mm visual analog scale, higher values represent more pain.

    Day 1

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.

Drug: Placebo gel

Study Group

EXPERIMENTAL

Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.

Drug: 2% lidocaine gel

Interventions

2% lidocaine gelDRUG

120mg lidocaine x 1

Study Group
Placebo gelDRUG

Inert gel x 1

Control Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • plans for IUD insertion for contraception or abnormal uterine bleeding;
  • to 49 years of age;
  • reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;
  • no prior IUD use;
  • not taken analgesics or anxiolytics in the previous 24 hours;
  • not taken misoprostol prior to IUD insertion;
  • the ability and are willing to give informed consent;
  • speaks English or Spanish.

You may not qualify if:

  • any contraindication to IUD placement;
  • allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;
  • chronic narcotic/benzodiazepine/barbiturate use within the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Primary Care Center/Women and Infants' Hospital

Providence, Rhode Island, 02905, United States

Location

Womens Primary Care Center

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

  • Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.

    PMID: 24012096DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Rebecca Allen
Organization
Women and Infants Hospital
rhallen@wihri.org
4012741122

Study Officials

  • Rebecca H Allen, MD, MPH

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor ob/gyn

Study Record Dates

First Submitted

January 24, 2011

First Posted

February 9, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 2, 2020

Results First Posted

September 2, 2020

Record last verified: 2020-08

Locations

US(2)