Opioid Reduction Program for Total Knee Replacement Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty

NCT04314505

Knee Replacement Postoperative Pain Opioid Use

UNKNOWN PHASE4

Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption

NCT03534102

Opioid Use Opioid Dependence Knee Pain Chronic +1 more

WITHDRAWN PHASE4

Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA

NCT06691633

Osteoarthritis (OA) of the Knee

COMPLETED PHASE4

Opioid Induced Loss of Local Anesthetic Potency in Patients Undergoing Total Knee Arthroplasty

NCT03294174

Opioid Tolerance, Opioid Naive, Opioid Exposure

TERMINATED

NSAIDS vs Opioids in Tibial Fractures

NCT05332314

Trauma

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.

There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Injuries Knee Injuries and Disorders Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment As Usual (TAU)

No intervention will be administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Opioid Reduction Program

Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery.

Group Type EXPERIMENTAL

Opioid Reduction Program

Intervention Type BEHAVIORAL

Subjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Opioid Reduction Program

Subjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TKR-ORP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years or older.
* Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
* Access to a telephone.
* Able to consent in English.

Exclusion Criteria

* Under the age of 18.
* Contraindications to use of opioid medication.
* No access to a telephone.
* Unable to understand consent materials in English.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No