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

NCT05498025 | Completed

• 1 other identifier: 2022-0487
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Opioid Misuse; Obstetric Pain; Cesarean Section Complications

Keywords

opioid disposal; drug deactivation; Deterra

Outcome Measures

Primary Outcomes (1)

• Actual pouch use

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

  30 days

Study Arms (1)

Activated charcoal pouch

EXPERIMENTAL

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

Interventions

Deterra activated charcoal pouch OTHER

drug disposal pouch

Activated charcoal pouch

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Acute Pain; Opioid-Related Disorders; Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael J Paglia

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective single arm interventional pilot study.

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: August 11, 2022
• Study Start: February 21, 2023
• Primary Completion: July 29, 2023
• Study Completion: July 29, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)