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

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.

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Key information

Conditions

Pain, Acute Acute Pain Cesarean Section Complications Chemically-Induced Disorders Labor Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Obstetric Pain Opioid Misuse Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deterra activated charcoal pouch

Other

drug disposal pouch

Primary outcomes

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 (%)

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Aug 11, 2022
Registry last updated: Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed