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

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Geisinger Health

Status

Completed

Conditions

Cesarean Section Complications
Obstetric Pain
Pain, Acute
Opioid Misuse

Treatments

Other: Deterra activated charcoal pouch

Study type

Interventional

Funder types

Other

Identifiers

NCT05498025
2022-0487

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

Activated charcoal pouch
Experimental group
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.
Treatment:
Other: Deterra activated charcoal pouch

Trial contacts and locations

1

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Central trial contact

Richard Vigh

Data sourced from clinicaltrials.gov

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