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

Sponsor

TriHealth Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT02799641

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Diazepam Drug: Lidocaine Other: Placebo pill Other: Placebo injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Control arm receives ibuprofen, placebo pill, and placebo injection.	Other: Placebo pill Placebo pill Other: Placebo injection Placebo injection
Experimental: Treatment Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.	Drug: Diazepam 5 mg Diazepam Other Names: Valium Drug: Lidocaine 2 ml of 2% lidocaine Other Names: Xylocaine

Arm

Intervention/Treatment

Placebo Comparator: Control

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

Other: Placebo pill

Placebo pill

Other: Placebo injection

Placebo injection

Experimental: Treatment

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

Drug: Diazepam

5 mg Diazepam

Other Names:

Valium

Drug: Lidocaine

2 ml of 2% lidocaine

Other Names:

Xylocaine

Outcome Measures

Primary Outcome Measures

VAS (Visual Analog Score) pain score [At IUD insertion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.