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

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05498025

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Opioid Misuse Obstetric Pain Cesarean Section Complications	Other: Deterra activated charcoal pouch	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a prospective single arm interventional pilot study.This is a prospective single arm interventional pilot study.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Deterra activated charcoal pouch drug disposal pouch

Arm

Intervention/Treatment

Experimental: 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.

Other: Deterra activated charcoal pouch

drug disposal pouch

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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