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Completed

NCT Number: NCT04083209

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Methodist Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Opioid counseling

Behavioral

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

Primary outcomes

  1. Quantity of opioid pain medication used

    Time frame: 2 weeks

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

Secondary outcomes

  1. VAS pain scores

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Effect of Preoperative Counseling on Postoperative Opioid Use Following Knee Arthroscopy. A Randomized Controlled Trial.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
May 14, 2021

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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