NCT01411995

Brief Summary

The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 9, 2018

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

August 3, 2011

Results QC Date

January 12, 2016

Last Update Submit

February 9, 2018

Conditions

Pain

Keywords

intrauterine devicepainlidocaine gel

Outcome Measures

Primary Outcomes (1)

  • Pain Score Assessed Immediately Following IUD Insertion

    Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required. Range: 0-10 (0= no pain, 10=worst pain)

    Immediately following IUD insertion

Study Arms (2)

2% Lidocaine gel

EXPERIMENTAL

Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal

Drug: 2% lidocaine gel

Water based lubricant

PLACEBO COMPARATOR

Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal

Drug: Water based lubricant

Interventions

2% lidocaine gelDRUG

3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion

Also known as: Lidocaine
2% Lidocaine gel
Water based lubricantDRUG

3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion

Also known as: KY gel
Water based lubricant

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45 yrs
  • selecting intrauterine device contraception
  • able and willing to consent

You may not qualify if:

  • non-English speaking
  • current intrauterine device use
  • expulsion of intrauterine device within 2 weeks
  • allergy to lidocaine or water based lubricant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Research at Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

  • Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. doi: 10.1363/psrh.38.090.06.

    PMID: 16772190BACKGROUND

  • Kulier R, O'Brien PA, Helmerhorst FM, Usher-Patel M, D'Arcangues C. Copper containing, framed intra-uterine devices for contraception. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005347. doi: 10.1002/14651858.CD005347.pub3.

    PMID: 17943851BACKGROUND

  • Rivera R, Best K. Current opinion: consensus statement on intrauterine contraception. Contraception. 2002 Jun;65(6):385-8. doi: 10.1016/s0010-7824(02)00304-9.

    PMID: 12127634BACKGROUND

  • O'Brien PA, Kulier R, Helmerhorst FM, Usher-Patel M, d'Arcangues C. Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials. Contraception. 2008 May;77(5):318-27. doi: 10.1016/j.contraception.2007.12.011. Epub 2008 Mar 18.

    PMID: 18402846BACKGROUND

  • Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.

    PMID: 21508749BACKGROUND

  • Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available.

    PMID: 4612152BACKGROUND

  • Madden T, Allsworth JE, Hladky KJ, Secura GM, Peipert JF. Intrauterine contraception in Saint Louis: a survey of obstetrician and gynecologists' knowledge and attitudes. Contraception. 2010 Feb;81(2):112-6. doi: 10.1016/j.contraception.2009.08.002. Epub 2009 Sep 16.

    PMID: 20103447BACKGROUND

  • Buttram V, Izu A, Henzl MR. Naproxen sodium in uterine pain following intrauterine contraceptive device insertion. Am J Obstet Gynecol. 1979 Jul 1;134(5):575-8. doi: 10.1016/0002-9378(79)90844-5.

    PMID: 453298BACKGROUND

  • Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.

    PMID: 17074548BACKGROUND

  • Dijkhuizen K, Dekkers OM, Holleboom CA, de Groot CJ, Hellebrekers BW, van Roosmalen GJ, Janssen CA, Helmerhorst FM. Vaginal misoprostol prior to insertion of an intrauterine device: an RCT. Hum Reprod. 2011 Feb;26(2):323-9. doi: 10.1093/humrep/deq348. Epub 2010 Dec 15.

    PMID: 21159683BACKGROUND

  • Li YT, Kuo TC, Kuan LC, Chu YC. Cervical softening with vaginal misoprostol before intrauterine device insertion. Int J Gynaecol Obstet. 2005 Apr;89(1):67-8. doi: 10.1016/j.ijgo.2005.01.036. No abstract available.

    PMID: 15777909BACKGROUND

  • Saav I, Aronsson A, Marions L, Stephansson O, Gemzell-Danielsson K. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Hum Reprod. 2007 Oct;22(10):2647-52. doi: 10.1093/humrep/dem244. Epub 2007 Jul 25.

    PMID: 17652452BACKGROUND

  • Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.

    PMID: 19588429BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr Colleen McNicholas
Organization
Washington University School of Medicine
mcnicholasc@wudosis.wustl.edu
314-747-1331

Study Officials

  • Colleen P McNicholas, DO

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 8, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 9, 2018

Results First Posted

March 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)