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OpenTrials
Completed

NCT Number: NCT02799641

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

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.

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Key information

Conditions

Contraception Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diazepam

Drug

5 mg Diazepam

Other names: Valium

Lidocaine

Drug

2 ml of 2% lidocaine

Other names: Xylocaine

Placebo pill

Other

Placebo pill

Placebo Injection

Other

Placebo injection

Primary outcomes

  1. VAS (Visual Analog Score) pain score

    Time frame: At IUD insertion

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2016
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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