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

TriHealth

Status: Completed

Conditions: Contraception

Treatments: Drug: Diazepam; Other: Placebo injection; Drug: Lidocaine; Other: Placebo pill

Study type: Interventional

Funder types: Other

Identifiers

NCT02799641

15-062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Control arm receives ibuprofen, placebo pill, and placebo injection.

Treatment:

Other: Placebo injection

Other: Placebo pill

Treatment

Experimental group

Description:

Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.

Treatment:

Drug: Lidocaine

Drug: Diazepam