OPIOID Study - Pain With Osmotic Dilators

Study Overview
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Brief Summary
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Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.

Detailed Description
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This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D&E) procedures. Pain levels and medication usage will also be assessed following the D&E procedure itself, up to 7 days after the procedure.

Official Title
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OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators

Conditions
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Abortion in Second Trimester

Intervention / Treatment
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* Device: Dilapan-S
* Device: Laminaria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled D&E for 15+0 to 23+6 wga ability to speak and read in English ownership of smartphone with internet access and data plan Exclusion Criteria: - chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics

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
Interventional Model Description: Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dilapan-S<br>Synthetic osmotic dilator | Device: Dilapan-S<br>* Synthetic osmotic dilator<br>|
| Active Comparator: Laminaria<br>Seaweed-based osmotic dilator | Device: Laminaria<br>* Seaweed-based osmotic dilator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain above baseline following Laminaria versus Dilapan-S placement | Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement | First 24 hours after dilator placement | 
| Time of maximum pain above baseline following Laminaria versus Dilapan-S placement | Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement | First 24 hours after dilator placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medication use after Laminaria versus Dilapan-S placement | Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement | First 24 hours after dilator placement | 
| Maximum pain increase over baseline following D&E procedure | Timed surveys measuring pain on Numeric Rating Scale (0-10), administered at 1 hour, 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure | First week after D&E | 
| Pain medication use after D&E | Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure | First week after D&E |