NCT02799641

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Diazepam	5 mg Diazepam
DRUG	Lidocaine	2 ml of 2% lidocaine
OTHER	Placebo pill	Placebo pill
OTHER	Placebo injection	Placebo injection

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2016-06-15
• Last updated: 2023-08-04

Locations

1 site across 1 country: United States