Study Results
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Basic Information
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COMPLETED
PHASE4
98 participants
INTERVENTIONAL
2015-01-31
2016-07-31
Brief Summary
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Detailed Description
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A major barrier to young women's utilization of IUSs is fear of pain during insertion. Unfortunately, studies evaluating methods of pain control during IUS insertion have focused on adult women, leaving the question unanswered as to the best pain management method for young women. Compared to adult women, young women have less experience with pelvic exams and may therefore derive greater benefit from pain control measures during gynecologic procedures, such as IUS insertions. Young women and their providers are seeking effective pain control options; yet, there is a lack of high quality, comparative effectiveness research to guide decision making. This proposal seeks to fill this important gap.
With the introduction of the Skyla IUS (Bayer Healthcare Pharmaceuticals, Inc.) to the U.S. market in January 2013, a new approach to pain management became possible. Skyla is smaller than existing IUSs and may therefore cause less pain during insertion. The pain response triggered during Skyla insertion may be better controlled by existing pain control options. This is the underlying premise of this study.
In addition to the size of an IUS, theoretical and empirical data suggest that paracervical blocks have the greatest promise for pain control during IUS insertion compared to other pain control options. Paracervical infiltration of a local anesthetic into the cervix interrupts the visceral sensory fibers of the lower uterus, cervix, and upper vagina. Data from several clinical trials indicate that paracervical blocks provide clinically significant control of pain during multiple types of gynecologic procedures. One recently published study evaluated the effectiveness of paracervical blocks during IUS insertion and found a marginally significant reduction in pain, but the study was underpowered and focused on adult women. The value of a paracervical block in young women receiving an IUS remains unclear.
The investigator propose to conduct a randomized, controlled single-blind trial comparing pain with Skyla IUS insertion among young women aged 14 to 22 years randomized to receive a paracervical block versus a sham cervical block. This study will provide important information for counseling young women about pain management during IUS insertion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Paracervical Nerve Block
Ten milliliters of 1% lidocaine paracervical anesthetic will be injected at three cervical locations: 1 mL at the tenaculum site (12 o'clock on a clock face) and 4.5 mL each at the 4 o'clock and 8 o'clock positions. A 3 minute waiting period will be used between the administration of the paracervical nerve block and the insertion of IUS to allow the paracervical block to take effect.
Paracervical Nerve Block
Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Sham Paracervical Block
To perform the sham cervical block, the cervix will be touched with the blunt end of a Q-tip at the three locations described above for the paracervical block. The cervical mucosa will not be broken during the sham block. A 3 minute waiting period will again occur between administration of the sham block and IUS insertion to be consistent with the procedure used for the nerve block.
Sham Paracervical Block
Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Interventions
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Paracervical Nerve Block
Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Sham Paracervical Block
Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not currently pregnant
* Not pregnant in the past 6 weeks
* Willing to be randomized to a paracervical nerve block or sham paracervical block group
* Interested in using an intrauterine system (IUS)
* Able to read and provide written informed consent in English
Exclusion Criteria
* A history of epilepsy or peptic ulcer disease
* Moderate to severe asthma that precludes non-steroidal anti-inflammatory drug (NSAID) use
* Hepatic or renal failure
* Moderate to severe cardiac disease
* Previous use of an IUS or a history of a prior failed IUS insertion
* Use of a narcotic or benzodiazepine in the past 24 hours
* Positive pregnancy test or reasonable risk of pregnancy
* Current cervicitis
* Intrauterine infection in the past 90 days
* Meet Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for IUS use
* Currently breastfeeding
14 Years
22 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
University of Pennsylvania
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Aletha Y Akers, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Countries
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References
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Kavanaugh ML, Jerman J, Hubacher D, Kost K, Finer LB. Characteristics of women in the United States who use long-acting reversible contraceptive methods. Obstet Gynecol. 2011 Jun;117(6):1349-1357. doi: 10.1097/AOG.0b013e31821c47c9.
Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13.
Finer LB. Unintended pregnancy among U.S. adolescents: accounting for sexual activity. J Adolesc Health. 2010 Sep;47(3):312-4. doi: 10.1016/j.jadohealth.2010.02.002. Epub 2010 Apr 9.
Kavanaugh ML, Frohwirth L, Jerman J, Popkin R, Ethier K. Long-acting reversible contraception for adolescents and young adults: patient and provider perspectives. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):86-95. doi: 10.1016/j.jpag.2012.10.006. Epub 2012 Dec 31.
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.
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.
Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.
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.
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.
Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012 Dec;86(6):704-9. doi: 10.1016/j.contraception.2012.06.004. Epub 2012 Jul 6.
Bednarek PH, Micks EA, Edelman AB, Li H, Jensen JT. The effect of nitroprusside on IUD insertion experience in nulliparous women: a pilot study. Contraception. 2013 Apr;87(4):421-5. doi: 10.1016/j.contraception.2012.10.030. Epub 2012 Dec 4.
McNicholas CP, Madden T, Zhao Q, Secura G, Allsworth JE, Peipert JF. Cervical lidocaine for IUD insertional pain: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):384.e1-6. doi: 10.1016/j.ajog.2012.09.018. Epub 2012 Sep 20.
Tangsiriwatthana T, Sangkomkamhang US, Lumbiganon P, Laopaiboon M. Paracervical local anaesthesia for cervical dilatation and uterine intervention. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD005056. doi: 10.1002/14651858.CD005056.pub2.
Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. doi: 10.1002/14651858.CD006106.pub2.
Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
Karabayirli S, Ayrim AA, Muslu B. Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):581-4. doi: 10.1016/j.jmig.2012.04.004. Epub 2012 Jul 4.
Jensen HH, Blaabjerg J, Lyndrup J. [Prophylactic use of prostaglandin synthesis inhibitors in connection with IUD insertion]. Ugeskr Laeger. 1998 Nov 23;160(48):6958-61. Danish.
Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.
Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
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.
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.
Akers AY, Harding J, Perriera LK, Schreiber C, Garcia-Espana JF, Sonalkar S. Satisfaction With the Intrauterine Device Insertion Procedure Among Adolescent and Young Adult Women. Obstet Gynecol. 2018 Jun;131(6):1130-1136. doi: 10.1097/AOG.0000000000002596.
Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.
Other Identifiers
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14-011286
Identifier Type: -
Identifier Source: org_study_id
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