FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

Kaiser Permanente

Status: Completed

Conditions: Post-operative Pain

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02576392

FDA BAA HHSF223201400146C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 561 patients

Sex: All

Ages: 20 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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561 participants in 2 patient groups

Intervention

Experimental group

Description:

Informational letter mailed approximately 2 weeks prior to surgery, informational letter mailed approximately 2 weeks post surgery, pharmacist call if refill opioid medicine more than 28 days after surgery

Treatment:

Behavioral: Intervention

Control

No Intervention group

Description:

Usual Care