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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02799641

Enrollment

Registered

2016-06-15

Start date

2016-07-31

Completion date

2022-06-30

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Contraception, IUD, levonorgestrel releasing intrauterine device, lidocaine, valium, diazepam, pain, VAS, visual analog scale

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.

Interventions

DRUGDiazepam

5 mg Diazepam

DRUGLidocaine

2 ml of 2% lidocaine

OTHERPlacebo pill

Placebo pill

OTHERPlacebo injection

Placebo injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
VAS (Visual Analog Score) pain score	At IUD insertion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026