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FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02576392
Acronym
FLOOD
Enrollment
561
Registered
2015-10-15
Start date
2015-07-01
Completion date
2017-03-31
Last updated
2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Brief 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.

Detailed 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.

Interventions

BEHAVIORALIntervention

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.

Sponsors

Food and Drug Administration (FDA)
CollaboratorFED
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average morphine equivalents90 dayspost surgery use of opioids

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026