The Excess Opioid Disposal Study

Surgical Procedures, Operative Clinical Trial

Official title:

The Excess Opioid Disposal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694899
• Other study ID #: D19001
• Status: Completed
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the hypothesis that providing information to patients about excess opioid disposal, calling patients prior to their outpatient post-operative surgical appointment and providing a convenient drop box for opioid disposal will increase rates of FDA compliant disposal.

Description:

It is hypothesized that:

1. By providing pre-operative patient education, a drop-box in a convenient location (the hospital pharmacy near the surgical outpatient clinic) and a reminder phone call prior to the post-operative clinic appointment, an increase in FDA-compliant unused opioid disposal rates to at least 40% will be seen.

2. The investigator's guideline for opioid prescribing after operations that require an inpatient admission which the investigator established for general surgical procedures will satisfy the opioid requirements of at least 85% of patients undergoing a variety of operations from differing specialties.

3. The utilization of guideline opioid prescribing and FDA-compliant unused opioid disposal will decrease the percentage of patients who are taking opioids at 6 months and 1 year after their surgery to less than 1%.

The primary objective is to determine the effect of pre-operative patient education, a drop-box in the hospital pharmacy and a reminder phone call on the proportion of patients who dispose of unused opioids using a FDA-compliant method.

Secondary objectives include:

1. Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations.

2. Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having surgery with expected duration of admission of 2 days or more

Exclusion Criteria:

• Allergies to opioids

• Allergy or contra-indication to short term acetaminophen or ibuprofen

• Chronic opioid use

• History of opioid abuse

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

Behavioral:
• phone contact
patients will be called prior to their outpatient appointment

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid disposal rate	% of patients that dispose of excess opioids in an FDA compliant manner	1 year
Secondary	Does guideline predict opioid needs	1.Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations.	6 months
Secondary	effect on long term opioid usage	Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery.	1 year