Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD

Contraception Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled Study on the Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing Intrauterine System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799641
• Other study ID #: 15-062
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2022

Study information

• Verified date: August 2023
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does the addition of cervical lidocaine injections and valium to the current practice result in decreased reported pain with tenaculum placement, IUD insertion, and post procedural discomfort? The current practice is ibuprofen alone or no medication.

Description:

Long acting reversible contraception, including intrauterine devices (IUDs), provide birth control for an extended period of time. IUDs are the most effective type of reversible birth control for women who do not wish to become pregnant over the next couple years, have the lowest failure rate (Winner, 2012), and in 2007, were used by more than 180 million women worldwide (Darney, 2010). Despite the high efficacy and low rates of side effects, women may decline placement of an IUD due to fear of pain associated with placement. IUDs may act as a barrier to women selecting this method of contraception. Currently there is no consensus in the literature as to the most effective way to address analgesia surrounding IUD insertion.

In order to eliminate barriers to selecting the IUD for contraception, improve the experience of women undergoing placement, and standardize local practices, investigators want to investigate analgesic options affecting patients' perception of pain during the various steps of IUD insertion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age,

• Desires to undergo placement of a levonorgestrel containing intrauterine device

Exclusion Criteria:

• Device manufacturer contraindications such as signs of genital infection, positive urine pregnancy test, abnormal vaginal bleeding, abnormal sized uterus that sounds <6cm or >10cm, and all other contraindications to placement of a levonorgestrel containing IUD.

• Patients with a history of drug abuse.

• History of a prior IUD

• Current use of medications for anxiety

• Also, a diagnosis of chronic pain.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Diazepam
5 mg Diazepam
• Lidocaine
2 ml of 2% lidocaine

Other:
• Placebo pill
Placebo pill
• Placebo injection
Placebo injection

Locations

Country	Name	City	State
United States	Bethesda North Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & Publications (26)

Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012 Jun;85(6):558-62. doi: 10.1016/j.contraception.2011.10.015. Epub 2011 Dec 15. — View Citation

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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

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Pergialiotis V, Vlachos DG, Protopappas A, Vlachos GD. Analgesic options for placement of an intrauterine contraceptive: a meta-analysis. Eur J Contracept Reprod Health Care. 2014 Jun;19(3):149-60. doi: 10.3109/13625187.2014.903238. Epub 2014 May 14. — View Citation

Polyzos NP, Zavos A, Valachis A, Dragamestianos C, Blockeel C, Stoop D, Papanikolaou EG, Tournaye H, Devroey P, Messinis IE. Misoprostol prior to hysteroscopy in premenopausal and post-menopausal women. A systematic review and meta-analysis. Hum Reprod Update. 2012 Jul;18(4):393-404. doi: 10.1093/humupd/dms014. Epub 2012 Apr 27. — View Citation

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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. — View Citation

Scavuzzi A, Souza AS, Costa AA, Amorim MM. Misoprostol prior to inserting an intrauterine device in nulligravidas: a randomized clinical trial. Hum Reprod. 2013 Aug;28(8):2118-25. doi: 10.1093/humrep/det240. Epub 2013 Jun 5. — View Citation

Talamo G, Liao J, Bayerl MG, Claxton DF, Zangari M. Oral administration of analgesia and anxiolysis for pain associated with bone marrow biopsy. Support Care Cancer. 2010 Mar;18(3):301-5. doi: 10.1007/s00520-009-0652-0. Epub 2009 May 21. — View Citation

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Waddington A, Reid R. More harm than good: the lack of evidence for administering misoprostol prior to IUD insertion. J Obstet Gynaecol Can. 2012 Dec;34(12):1177-1179. doi: 10.1016/S1701-2163(16)35465-2. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS (Visual Analog Score) pain score		At IUD insertion