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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Deterra activated charcoal pouch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective single arm interventional pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated charcoal pouch<br>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<br>* drug disposal pouch<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid disposal, drug deactivation, Deterra