OPIOID Study - Pain With Osmotic Dilators (OPIOID)

March 13, 2020 updated by: Albany Medical College

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dilapan-S
Synthetic osmotic dilator
Device: Dilapan-S
Synthetic osmotic dilator
Active Comparator: Laminaria
Seaweed-based osmotic dilator
Device: Laminaria
Seaweed-based osmotic dilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum pain above baseline following Laminaria versus Dilapan-S placement
Time Frame: First 24 hours after dilator 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
Time Frame: First 24 hours after dilator 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
Time Frame: 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
First 24 hours after dilator placement
Maximum pain increase over baseline following D&E procedure
Time Frame: 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
First week after D&E
Pain medication use after D&E
Time Frame: 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
First week after D&E

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2018

Primary Completion (Actual)

March 11, 2020

Study Completion (Actual)

March 11, 2020

Study Registration Dates

First Submitted

October 14, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 5209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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