Cervical Lidocaine for Intrauterine Device Insertion Pain - Full Text View

Purpose

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 IUD 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.

Condition	Intervention
Pain Intrauterine Device	Drug: 2% lidocaine gel Drug: Water based lubricant

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: Prevention
Official Title:	RCT of Cervical Lidocaine for Intrauterine Device Insertion Pain

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Pain score [ Time Frame: Immediately following insertion ] [ Designated as safety issue: No ]
Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure.The entirety of teh procedure should last no more than 5-10 minuites. The pain score is assessed at the 3 timepoints within that 10 minuite window. No additional followup is required.

Estimated Enrollment:	200
Study Start Date:	August 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2% Lidocaine gel 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 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion
Placebo Comparator: Water based lubricant 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 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411995

Contacts

Contact: Colleen P McNicholas, DO

314-747-6721

mcnicholasc@wudosis.wustl.edu

Locations

United States, Missouri
Division of Clinical Research at Washington University	Recruiting
St Louis, Missouri, United States, 63110
Contact: Colleen P McNicholas, DO 314-747-6721 mcnicholasc@wudosis.wustl.edu
Sub-Investigator: Colleen P McNicholas, DO
Principal Investigator: Tessa Madden, Md, MPh

Sponsors and Collaborators

Washington University School of Medicine

More Information

Publications:

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.

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;(4):CD005347. Review.

Rivera R, Best K. Current opinion: consensus statement on intrauterine contraception. Contraception. 2002 Jun;65(6):385-8. Review.

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. Epub 2008 Mar 18. Review.

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):1105-13.

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.

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. Epub 2009 Sep 16.

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.

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.

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. Epub 2010 Dec 15.

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. No abstract available.

Sääv 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. Epub 2007 Jul 25.

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. Review.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01411995 History of Changes
Other Study ID Numbers:	201105067
Study First Received:	August 3, 2011
Last Updated:	November 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

intrauterine device
pain
lidocaine gel

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 May 16, 2013

Cervical Lidocaine for Intrauterine Device Insertion Pain (CLIIP)