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

Not Applicable

Completed

• Conditions: Pain; Contraception
• Interventions: Drug: placebo; Drug: Lidocaine; Drug: Naproxen

• Registration Number: NCT02769247
• Lead Sponsor: Walter Reed National Military Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-06-21
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Results First Posted: 2018-11-08
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion
Naproxen/Normal saline	placebo	Patient will receive naproxen and intrauterine normal saline prior to IUD insertion
Placebo oral medication/Lidocaine	placebo	Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion
Placebo oral medication/Lidocaine	Lidocaine	Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion
Naproxen/Normal saline	Naproxen	Patient will receive naproxen and intrauterine normal saline prior to IUD insertion
Naproxen/Lidocaine	Naproxen	Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion
Naproxen/Lidocaine	Lidocaine	Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion

Primary Outcome Measures

Name	Time	Method
Pain Control With IUD Insertion	within 30 minutes after 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

Secondary Outcome Measures

Name	Time	Method
Physician Perceived Pain Control During IUD Insertion	within 30 minutes after 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
Difficulty IUD Insertion	within 30 minutes of IUD insertion	as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.
Patient Satisfaction With IUD	30 days post insertion	Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.
Perceived Pain 30 Days Post Insertion	30 days post IUD 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).

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States