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Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy.

Primary Purpose

Opioid Use, Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid counseling
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Use

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • IU Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Counseling group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

VAS pain scores
Patients will also be surveyed on their pain level postoperatively using the VAS pain scale. The scale is from 0-10 with 10 being the highest amount of pain. 0 representing no pain.

Full Information

First Posted
September 6, 2019
Last Updated
May 13, 2021
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04083209
Brief Title
Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy.
Official Title
Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Amid a national opioid epidemic, providers are looking for ways to minimize the utilization of narcotic and addictive pain medications while adequately treating acute and postoperative pain, all the while maintaining patient satisfaction. Much effort has been dedicated to studying non-narcotic alternative medications such as acetaminophen, NSAIDs, toradol, ketamine, ect., as well as multimodal strategies such as periaxial and perineural blockades. Little attention, however, has been given to the role we play as providers to help minimize the use of these addictive medications and the potential effect we have on changing patient behaviors. Alter et al1 published in the Journal of Hand Surgery their success of minimizing opioid use by simple preoperative counseling of patients undergoing carpal tunnel release surgery. They provided brief educational materials about the opioid epidemic and risks of these medications, as well as encouraging patients to utilize non-narcotic alternatives to control pain postoperatively. They saw a decrease in the amount of opioids used with no difference in pain scores in the group receiving this preoperative counseling. There are roughly 750,000 knee scopes performed each year in the United States. The incidence of chronic opioid use stemming from a short course of narcotics after elective knee arthroscopy has been shown to be up to 30%.2-4 The high volume of these procedures presents a unique opportunity to study trends in opioid use and pain control in the postoperative period in a prospective fashion. Study Design Patients scheduled to undergo knee arthroscopy by a single surgeon will be randomized into preoperative counseling or no counseling by simple randomization methods (computer generated "coin flip"). Those in the counseling group will receive a two minute talk during their preoperative appointment covering the risks of opioid medications, current public health situation regarding opioids, and alternative methods for pain control. They will also receive a one page document summarizing the Pennsylvania Orthopedic Society recommendations regarding opioid use that was used in previous research1. All patients will be prescribed the same pain medication and quantity (hydrocodone-acetaminophen 5-325 mg, 40 pills, 0 refills). Postoperatively, patients will be contacted via telephone on postoperative day three, asking what medication and how many pills they are taking daily for pain, as well as rating their daily pain level on a scale from 0-10. At their first postoperative follow-up appointment, they will again be asked about the quantity of pain medications used and pain level. After the first postoperative phone call, all data collection will be obtained at their regularly scheduled postoperative office visits, which occur at two and four weeks postoperatively. During all postoperative data collection time points we will also inquire and note all pain control measures, including ice, heat, compression, elevation, or other medications not commonly thought of as "pain medications". Data collection from each patient will be concluded at their one month postoperative visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will be randomized into a treatment and control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will undergo the standard preoperative evaluation by the senior author without any additional formal opioid counseling.
Intervention Type
Behavioral
Intervention Name(s)
Opioid counseling
Intervention Description
The formal opioid counseling will involve reading the recommendations for postoperative opioid use established by the Pennsylvania Orthopedic Society.
Primary Outcome Measure Information:
Title
Quantity of opioid pain medication used
Description
Patients will be tracked for the amount of opioid pain medication that is used during their postoperative course using a pill log.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
VAS pain scores
Description
Patients will also be surveyed on their pain level postoperatively using the VAS pain scale. The scale is from 0-10 with 10 being the highest amount of pain. 0 representing no pain.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged 18-60, undergoing knee arthroscopic meniscectomy surgery Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitch Beckert, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We plan to share all data collected from the study including non-identifiable patient demographics, pain scores, opioid medication utilization, complications, and study design.
Citations:
PubMed Identifier
30396797
Citation
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.
Results Reference
result
PubMed Identifier
24977636
Citation
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.
Results Reference
result
PubMed Identifier
28890331
Citation
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.
Results Reference
result

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Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy.

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