Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion

To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

Study Overview

• Status: Completed
• Conditions: Pain; Contraception
• Intervention / Treatment: Drug: placebo; Drug: Naproxen; Drug: Lidocaine

Detailed Description

This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.

The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
• age 18 years and older
• desiring Paragard or Mirena intrauterine device insertion

Exclusion Criteria:

• Current pregnancy
• cervical stenosis
• severe medical illness
• known allergy or sensitivity to lidocaine or naproxen
• peptic ulcer disease
• current pelvic inflammatory disease
• patients with known renal insufficiency
• patients using chronic NSAIDs or on chronic pain medication
• women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion	Drug: placebo; either normal saline or empty oral capsule
Experimental: Naproxen/Normal saline; Patient will receive naproxen and intrauterine normal saline prior to IUD insertion	Drug: placebo; either normal saline or empty oral capsule; Drug: Naproxen; Oral naproxen vs placebo
Experimental: Placebo oral medication/Lidocaine; Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion	Drug: placebo; either normal saline or empty oral capsule; Drug: Lidocaine; Intrauterine lidocaine vs normal saline
Experimental: Naproxen/Lidocaine; Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion	Drug: Naproxen; Oral naproxen vs placebo; Drug: Lidocaine; Intrauterine lidocaine vs normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Control With IUD Insertion	visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain	within 30 minutes after IUD insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Perceived Pain Control During IUD Insertion	visual analog scale (0-3) as assessed by physician within 30 minutes after IUD insertion Scale is from a minimum of 0, with maximum of 3 with higher scores denoting more pain	within 30 minutes after IUD insertion
Patient Satisfaction With IUD	Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.	30 days post insertion
Difficulty IUD Insertion	as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.	within 30 minutes of IUD insertion
Perceived Pain 30 Days Post Insertion	survey patient 30 days later to determine her recollection of pain during insertion (0-10); 10 being the most pain. One patient had no IUD initially inserted and was not included; each arm had patients lost to follow up (3 in placebo arm, 2 in naproxen arm, 4 in placebo/oral medication arm).	30 days post IUD insertion

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Investigators: Principal Investigator: Susan Dunlow, MD, WRNMMC

Publications and helpful links

General Publications

• Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pain; lidocaine; naproxen; intrauterine device; IUD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Gout Suppressants; Lidocaine; Naproxen
• Other Study ID Numbers: 384645-5