Clinical trial NCT02799641: Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD
Official title: Double-blind, Randomized, Placebo-controlled Study on the Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing Intrauterine System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
IUD
levonorgestrel releasing intrauterine device
lidocaine
valium
diazepam
pain
VAS
visual analog scale
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAS (Visual Analog Score) pain score
timeFrame: At IUD insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Catrina Crisp, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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