Pain Control for Intrauterine Device Placement Using Paracervical Block
NCT ID: NCT02219308
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2014-10-31
2017-10-31
Brief Summary
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Detailed Description
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Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Paracervical Block (PCB)
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
Paracervical Block (PCB)
Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds
No Paracervical Block (Sham PCB)
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
No Paracervical Block (Sham PCB)
Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
Interventions
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Paracervical Block (PCB)
Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds
No Paracervical Block (Sham PCB)
Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
Eligibility Criteria
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Inclusion Criteria
* English or Spanish speaking
* Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).
Exclusion Criteria
* Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
* If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
* Misoprostol administration within 24 hours of enrollment
* History of prior IUD insertion
* Known contraindications to IUD
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Sheila Mody
Women's Reproductive Health Research (K12) Scholar
Principal Investigators
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Sheila Mody, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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UCSD
San Diego, California, United States
Planned Parenthood Mission Bay Parker Center
San Diego, California, United States
Countries
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References
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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.
Cetin A, Cetin M. Effect of deep injections of local anesthetics and basal dilatation of cervix in management of pain during legal abortions. A randomized, controlled study. Contraception. 1997 Aug;56(2):85-7. doi: 10.1016/s0010-7824(97)00096-6.
Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.
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.
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.
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.
Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.
Phair N, Jensen JT, Nichols MD. Paracervical block and elective abortion: the effect on pain of waiting between injection and procedure. Am J Obstet Gynecol. 2002 Jun;186(6):1304-7. doi: 10.1067/mob.2002.123734.
Rabin JM, Spitzer M, Dwyer AT, Kaiser IH. Topical anesthesia for gynecologic procedures. Obstet Gynecol. 1989 Jun;73(6):1040-4. doi: 10.1097/00006250-198906000-00027.
Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.
Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. doi: 10.1016/0020-7292(95)02416-a.
Wiebe ER. Comparison of the efficacy of different local anesthetics and techniques of local anesthesia in therapeutic abortions. Am J Obstet Gynecol. 1992 Jul;167(1):131-4. doi: 10.1016/s0002-9378(11)91645-7.
Zieman, Mimi et al. A Pocket Guide to Managing Contraception. The Bridging Gap Foundation. © 2010
Zullo F, Pellicano M, Stigliano CM, Di Carlo C, Fabrizio A, Nappi C. Topical anesthesia for office hysteroscopy. A prospective, randomized study comparing two modalities. J Reprod Med. 1999 Oct;44(10):865-9.
Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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141025
Identifier Type: -
Identifier Source: org_study_id
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