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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.
Double blind randomized controlled trial.
Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% lidocaine gel | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen P McNicholas, DO | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Clinical Research at Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16772190 | Background | 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. | |
| 17943851 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| FG001 | 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 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 participant was excluded for failed IUD placement. The primary outcome could not be assessed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Median | Full Range | units on visual analog scale | Immediately following IUD insertion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Colleen McNicholas | Washington University School of Medicine | 314-747-1331 | mcnicholasc@wudosis.wustl.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Water based lubricant | Drug | 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 |
|
|
| 12127634 | Background | 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. |
| 18402846 | Background | 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. |
| 21508749 | Background | 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. |
| 4612152 | Background | 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. |
| 20103447 | Background | 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. |
| 453298 | Background | 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. |
| 17074548 | Background | 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. |
| 21159683 | Background | 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. |
| 15777909 | Background | 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. |
| 17652452 | Background | 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. |
| 19588429 | Background | 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. |
| 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 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | kg/m^2 | Number | participants |
|
| Parity | Number | participants |
|
| Education | Number | participants |
|
| History of abortion | Number | participants |
|
| IUD type | Number | participants |
|
| Clinician inserter | Number | participants |
|
| 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 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 |
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | 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 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 | 0 | 100 | 0 | 100 |
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| Aniline Compounds |
| D000588 | Amines |