OPIOID Study - Pain With Osmotic Dilators

Not Applicable

Completed

• Conditions: Abortion in Second Trimester
• Interventions: Device: Laminaria; Device: Dilapan-S

• Registration Number: NCT03710239
• Lead Sponsor: Albany Medical College

Brief Summary

Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.

Detailed Description

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.

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-18
• Status Verified: 2020-03
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-11
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminaria	Laminaria	Seaweed-based osmotic dilator
Dilapan-S	Dilapan-S	Synthetic osmotic dilator

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain medication use after D&E	First week after D&E	Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D\&E procedure
Pain medication use after Laminaria versus Dilapan-S placement	First 24 hours after dilator placement	Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement
Maximum pain increase over baseline following D&E procedure	First week after D&E	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

Trial Locations

Locations (1)

Albany Medical Center Obstetrics and Gynecology; 🇺🇸 Albany, New York, United States