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

NCT ID: NCT05498025

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2023-07-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Activated charcoal pouch

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.

Group Type: EXPERIMENTAL

Deterra activated charcoal pouch

Intervention Type: OTHER

drug disposal pouch

Interventions

Deterra activated charcoal pouch

drug disposal pouch

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Paglia, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Paglia

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Countries

United States

Other Identifiers

2022-0487

Identifier Type: -

Identifier Source: org_study_id