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

Primary Purpose

Pain, Acute, Opioid Misuse, Obstetric Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deterra activated charcoal pouch
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute focused on measuring opioid disposal, drug deactivation, Deterra

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Activated charcoal pouch

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Actual pouch use
    The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2022
    Last Updated
    August 10, 2022
    Sponsor
    Geisinger Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05498025
    Brief Title
    The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
    Official Title
    The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Geisinger Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Opioid Misuse, Obstetric Pain, Cesarean Section Complications
    Keywords
    opioid disposal, drug deactivation, Deterra

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a prospective single arm interventional pilot study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Activated charcoal pouch
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Deterra activated charcoal pouch
    Intervention Description
    drug disposal pouch
    Primary Outcome Measure Information:
    Title
    Actual pouch use
    Description
    The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)
    Time Frame
    30 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richard Vigh
    Phone
    570-271-6211
    Email
    rvigh@geisinger.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael J Paglia
    Organizational Affiliation
    Geisinger Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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