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

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

Detailed Description
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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.

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

Conditions
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Contraception, Pain

Intervention / Treatment
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* Drug: Naproxen
* Drug: Lidocaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD, intrauterine device, pain, naproxen, lidocaine