The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery

January 17, 2024 updated by: Michael J. Paglia, MD PhD, Geisinger Clinic

Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation.

Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery.

Methods: This is a prospective single arm interventional pilot study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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 Contact

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center

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 to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Age 18+ at time of enrollment, per ERM
  • Delivered ≥26.0 weeks, per ERM
  • Status post low transverse cesarean delivery, per ERM
  • Physically located on labor & delivery and is postpartum day #1 or #2 at time of enrollment, per ERM
  • Opioid prescription has been sent (per ERM) or will be sent (per obstetric team).

Exclusion criteria:

  • Positive urine toxicology anytime in pregnancy for non-prescription opioids, fentanyl, amphetamines, benzodiazepines, cannabinoids, LSD, or cocaine, per ERM.
  • Buprenorphine or methadone Rx, per ERM
  • Patient preferred communication language not English, per ERM

  • Documented history, per ERM:

    • Cannabinoid use disorder
    • Hypnotic use disorder
    • Opioid use disorder
    • Stimulant use disorder
    • Fibromyalgia
    • Sickle cell anemia
    • Lumbar disc herniation
    • Multiple sclerosis
    • Trigeminal neuralgia
    • Active cancer
    • Complex regional pain syndrome
    • Systemic lupus erythematosus
    • Rheumatoid arthritis

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activated charcoal pouch
The patients in this arm will receive an activated charcoal pouch (Deterra Medium Pouch, UPC #: 850006727001, Verde Environmental Technologies, Minnetonka, MN) for disposal of their opioids after their cesarean delivery pain has resolved.
Other: Deterra activated charcoal pouch
drug disposal pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actual pouch use
Time Frame: 30 days
The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)
30 days

Collaborators and Investigators

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

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Michael J Paglia, Geisinger Clinic

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)

February 21, 2023

Primary Completion (Actual)

July 29, 2023

Study Completion (Actual)

July 29, 2023

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0487

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

No

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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