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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05414942
Other study ID # 21-08206-XP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date May 25, 2022

Study information

Verified date November 2022
Source University of Tennessee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date May 25, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of Tennessee Health Science Center Memphis Tennessee

Sponsors (2)

Lead Sponsor Collaborator
University of Tennessee Campbell Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid pills (dose and type) prescribed by Campbell Clinic. transcribed from medical record at Campbell Clinic 12-weeks post-op.
Primary Opioid pills prescribed outside of Campbell Clinic. assessed via scan of prescription drug monitoring database for Tennessee 12-weeks post-op.
Primary Opioid pill count questionnaire. self-report from participant of how many opioids are left in the bottle at the 12 week assessment 12-weeks post-op.
Secondary KOOS Jr. There are 3 domains scored from the 7-item measure: Stiffness (1 item), assessed on a 1-5 scale from None to Extreme; Pain (4 items), assessed on a 1-5 scale from None to Extreme; Function, daily living (2 items), assessed on a 1-5 scale from None to Extreme 12-weeks post-op.
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