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Completed

NCT Number: NCT02576392

FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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.

Primary outcomes

  1. Average morphine equivalents

    Time frame: 90 days

    post surgery use of opioids

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

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

Acronym: FLOOD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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