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Completed

NCT Number: NCT02769247

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.

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Key information

Conditions

Contraception Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxen

Drug

Oral naproxen vs placebo

Lidocaine

Drug

Intrauterine lidocaine vs normal saline

Placebo

Drug

either normal saline or empty oral capsule

Primary outcomes

  1. Pain Control With IUD Insertion

    Time frame: 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 outcomes

  1. Physician Perceived Pain Control During IUD Insertion

    Time frame: 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

  2. Patient Satisfaction With IUD

    Time frame: 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.

  3. Difficulty IUD Insertion

    Time frame: within 30 minutes of IUD insertion

    as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.

  4. Perceived Pain 30 Days Post Insertion

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 11, 2016
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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