NCT04083209

Brief Summary

Our study looks to evaluate the effect of brief preoperative counseling on opioid use following knee arthroscopy. We aim to quantify the effect we have as providers in changing patient behavior postoperatively in terms of the type and amount of pain medication that is utilized.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

September 6, 2019

Last Update Submit

May 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantity of opioid pain medication used

    Patients will be tracked for the amount of opioid pain medication that is used during their postoperative course using a pill log.

    2 weeks

Secondary Outcomes (1)

  • VAS pain scores

    2 weeks

Study Arms (2)

Counseling group

EXPERIMENTAL

Patients randomized into the "counseling group" will be given a 1-2 minute presentation over the risks of opioid pain medications during their preoperative visit.

Behavioral: Opioid counseling

Control group

NO INTERVENTION

The control group will undergo the standard preoperative evaluation by the senior author without any additional formal opioid counseling.

Interventions

The formal opioid counseling will involve reading the recommendations for postoperative opioid use established by the Pennsylvania Orthopedic Society.

Counseling group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60, undergoing knee arthroscopic meniscectomy surgery

You may not qualify if:

  • Non-english speaking, prisoners, those who cannot provide consent on their own, previous history of chronic opioid use, prior history of surgery on the ipsilateral knee, and those undergoing additional surgical procedures on the same knee at the time of the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

  • Tepolt FA, Bido J, Burgess S, Micheli LJ, Kocher MS. Opioid Overprescription After Knee Arthroscopy and Related Surgery in Adolescents and Young Adults. Arthroscopy. 2018 Dec;34(12):3236-3243. doi: 10.1016/j.arthro.2018.07.021. Epub 2018 Nov 2.

  • Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.

  • Alter TH, Ilyas AM. A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery. J Hand Surg Am. 2017 Oct;42(10):810-815. doi: 10.1016/j.jhsa.2017.07.003. Epub 2017 Sep 8.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mitch Beckert, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Patients will be randomized into a treatment and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Clinical Professor

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

October 15, 2019

Primary Completion

June 26, 2020

Study Completion

June 26, 2020

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations