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

Study Overview
=================
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.

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

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Diazepam
* Drug: Lidocaine
* Other: Placebo pill
* Other: Placebo injection


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control arm receives ibuprofen, placebo pill, and placebo injection. | Other: Placebo pill<br>* Placebo pill<br>Other: Placebo injection<br>* Placebo injection<br>|
| Experimental: Treatment<br>Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection. | Drug: Diazepam<br>* 5 mg Diazepam<br>* Other names: Valium;Drug: Lidocaine<br>* 2 ml of 2% lidocaine<br>* Other names: Xylocaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analog Score) pain score |  | At IUD insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception, IUD, levonorgestrel releasing intrauterine device, lidocaine, valium, diazepam, pain, VAS, visual analog scale