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

NCT02799641 | Completed

• 1 other identifier: 15-062
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• VAS (Visual Analog Score) pain score

  At IUD insertion

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Placebo pill; Other: Placebo injection

Treatment

EXPERIMENTAL

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

Drug: Diazepam; Drug: Lidocaine

Interventions

Diazepam DRUG

5 mg Diazepam

Also known as: Valium

Treatment

Lidocaine DRUG

2 ml of 2% lidocaine

Also known as: Xylocaine

Treatment

Placebo pill OTHER

Placebo pill

Control

Placebo injection OTHER

Placebo injection

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age,
• Desires to undergo placement of a levonorgestrel containing intrauterine device

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Pain

Interventions

Diazepam; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Catrina Crisp, MD, MSc

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: June 15, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)