Study of Pain Control With Hormonal IUS Insertion

Pain Clinical Trial

— SOPHI  

Official title:

Study of Pain Control With Hormonal IUS Insertion (SOPHI Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352714
• Other study ID #: 14-011286
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2018
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a paracervical (n=46) block versus a sham paracervical block (n=46).

Description:

Intrauterine systems (IUS) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy. Despite this, uptake of IUSs among U.S. young women aged 14 to 22 years has been low. Increasing the use of this effective, long acting contraception among young women is an important public health goal, as it could help to reduce the high rates of unintended pregnancies in this population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 22 Years

Eligibility

Inclusion Criteria:

• Nulliparous (i.e., no pregnancy > 24 weeks)

• 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:

• An allergy, hypersensitivity, or absolute medical contra-indication to using lidocaine, other amino-amide local anesthetics, or to non-steroidal anti-inflammatory agents, such as ibuprofen

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Bayer, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (21)

Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. Review. Update in: Cochrane Database Syst Rev. 2015;9:CD006106. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD007373. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):1349-57. doi: 10.1097/AOG.0b013e31821c47c9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-2. Review. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2013;9:CD005056. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain	The primary outcome will be assessed using a visual analogue scale (VAS). Assessment will occur at the time of the insertion of the IUS device. The IUS will be placed according to manufacturer's recommendation.	Intraoperative (At the time of insertion of the IUS)