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ContraceptionNCT02799641

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

A study testing Diazepam and Lidocaine in people with Contraception, run by TriHealth Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Diazepam and Lidocaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteUnited States
Study dates
Jul 2016to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Over 18 years of age,
  • Desires to undergo placement of a levonorgestrel containing intrauterine device

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Contraception
Being tested
Diazepam, Lidocaine, Placebo pill, Placebo injection
Keywords
Contraception, IUD, levonorgestrel releasing intrauterine device, lidocaine, valium, diazepam, pain, VAS, visual analog scale
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiazepamDrug

    Also called Valium

    5 mg Diazepam

  • LidocaineDrug

    Also called Xylocaine

    2 ml of 2% lidocaine

  • Placebo pillOther

    Placebo pill

  • Placebo injectionOther

    Placebo injection

Study groups in NCT02799641
Study groupRoleWhat they receive
ControlPlacebo comparatorControl arm receives ibuprofen, placebo pill, and placebo injection.
Receives: Other: Placebo pill; Other: Placebo injection
TreatmentExperimentalTreatment arm receives ibuprofen, diazepam pill, and lidocaine injection.
Receives: Drug: Diazepam; Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS (Visual Analog Score) pain score

    Measured: At IUD insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJun 2022
  4. Study completionJun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799641
Sponsor's protocol ID
15-062
Status last verified
Aug 2023
First submitted
28 Oct 2015
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Romero L, Pazol K, Warner L, Gavin L, Moskosky S, Besera G, Loyola Briceno AC, Jatlaoui T, Barfield W; Centers for Disease Control and Prevention (CDC). Vital signs: trends in use of long-acting reversible contraception among teens aged 15-19 years seeking contraceptive services-United States, 2005-2013. MMWR Morb Mortal Wkly Rep. 2015 Apr 10;64(13):363-9.

    PubMed 25856258

  • Li R, Ruckle HC, Creech JD, Culpepper DJ, Lightfoot MA, Alsyouf M, Nicolay L, Jellison F, Baldwin DD. A prospective, randomized, controlled trial assessing diazepam to reduce perception and recall of pain during transrectal ultrasonography-guided biopsy of the prostate. J Endourol. 2014 Jul;28(7):881-6. doi: 10.1089/end.2014.0043. Epub 2014 May 5.

    PubMed 24641687

  • 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.

    PubMed 24828514

  • Ekelund M, Melander M, Gemzell-Danielsson K. Intrauterine contraception: attitudes, practice, and knowledge among Swedish health care providers. Contraception. 2014 May;89(5):407-12. doi: 10.1016/j.contraception.2013.12.014. Epub 2014 Jan 7.

    PubMed 24485096

  • Goldthwaite LM, Baldwin MK, Page J, Micks EA, Nichols MD, Edelman AB, Bednarek PH. Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial. Contraception. 2014 Mar;89(3):229-33. doi: 10.1016/j.contraception.2013.11.018. Epub 2013 Dec 10.

    PubMed 24405796

  • Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.

    PubMed 23860442

  • 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.

    PubMed 23739219

  • Ibrahim ZM, Sayed Ahmed WA. Sublingual misoprostol prior to insertion of a T380A intrauterine device in women with no previous vaginal delivery. Eur J Contracept Reprod Health Care. 2013 Aug;18(4):300-8. doi: 10.3109/13625187.2013.800855. Epub 2013 Jun 10.

    PubMed 23751152

  • 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.

    PubMed 23231800

  • Rossi V, Pourtois G. Transient state-dependent fluctuations in anxiety measured using STAI, POMS, PANAS or VAS: a comparative review. Anxiety Stress Coping. 2012 Nov;25(6):603-45. doi: 10.1080/10615806.2011.582948. Epub 2011 Aug 10.

    PubMed 21827372

  • 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.

    PubMed 22544173

  • 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.

    PubMed 22176793

  • Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, Secura GM. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012 May 24;366(21):1998-2007. doi: 10.1056/NEJMoa1110855.

    PubMed 22621627

  • 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.

    PubMed 21843686

  • Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12.

    PubMed 21477680

Questions about this trial

What is this clinical trial studying?

A study testing Diazepam and Lidocaine in people with Contraception, run by TriHealth Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS (Visual Analog Score) pain score (time frame: At IUD insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02799641, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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