FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

Post-operative Pain Clinical Trial

— FLOOD  

Official title:

Reducing the Use of Opioid Therapy Following Orthopedic Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576392
• Other study ID #: FDA BAA HHSF223201400146C
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: June 2, 2017
• Start date: July 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized trial evaluates an intervention to minimize use of opioids following total hip and total knee replacement. Half the participants will receive an intervention (mailed educational materials, followed by a pharmacist call), and half will receive usual care.

Description:

Surgeons and anesthesiologists prescribe opioids and other analgesic medications for acute, post-surgical pain. Recent studies have reported that some patients persist in taking opioids for months beyond the surgery. While opioids are commonly used for pain management following surgery, patients and their providers often don't have a planned method to optimize opioid exposure. This can lead to patients entering a cycle of opioid use that is difficult to manage, because, as opioid exposure is continued, pain relief is reduced and side effects increase. The investigators' study is aimed at reducing opioid exposure following total hip and total knee replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

Inclusion Criteria:

• total hip replacement or total knee replacement

• 1 year membership with KPNW prior to enrollment

Exclusion Criteria:

• managed by pain clinic, in other pain management trial

• patients at low risk of persistent opioid use

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Behavioral:
• Intervention
Intervention consisted of a mailing 2 weeks prior to surgery, another 2 weeks post surgery, and a pharmacist intervention if a refill of opioid medication was requested within 90 days of surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Food and Drug Administration (FDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average morphine equivalents	post surgery use of opioids	90 days