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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Drug: Diazepam; Other: Placebo pill; Other: Placebo injection; Drug: Lidocaine

• Registration Number: NCT02799641
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-15
• Study Start: 2016-07
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo injection	Control arm receives ibuprofen, placebo pill, and placebo injection.
Treatment	Diazepam	Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.
Control	Placebo pill	Control arm receives ibuprofen, placebo pill, and placebo injection.
Treatment	Lidocaine	Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.

Primary Outcome Measures

Name	Time	Method
VAS (Visual Analog Score) pain score	At IUD insertion

Trial Locations

Locations (1)

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States