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NCT05498025 Clinical Trial

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

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05498025
Other study ID # 2022-0487
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2023
Est. completion date July 29, 2023

Study information
Verified date January 2024
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date July 29, 2023
Est. primary completion date July 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Deterra activated charcoal pouch
drug disposal pouch

Locations
Country Name City State
United States Geisinger Medical Center Danville Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Actual pouch use The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%) 30 days
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