Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction (CARE)

March 28, 2024 updated by: Jonathan D. Packer, MD, University of Maryland, Baltimore

Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Research question: Does an opioid limiting pain management counseling and education program result in decreased opioid consumption and improved pain control compared to traditional pain management programs after anterior cruciate ligament reconstruction (ACLR) surgery?

At many institutions, the current standard of care is to instruct patients to take opioid pain medicine as needed when in severe pain to "stay ahead of the pain." This study is investigating whether modifying the instructions to take opioid pain medications only if in "unbearable pain" will have an effect on 1) reducing opioid consumption and 2) improving pain levels.

Adults who are undergoing an ACLR surgery will be invited to participate in the study and be randomly assigned to one of the two pain management programs. All patients will receive a comprehensive multi-modality pain management treatments and medications. Patients in both groups will receive the same type and amount of all postoperative medications. The only difference will be in the instructions about when to take the opioid medications.

The patients will then be sent an electronic survey twice per day for 2 weeks about their pain levels and number of opioid pills taken.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prescription narcotic pain medications (opioids) were responsible for roughly 17,000 deaths in 2016 in the United States. Orthopedic surgeons were responsible for prescribing the third highest percentage of opioids among physicians in 2009. In recent years, orthopaedic surgeons have used many different types of non-opioid pain medications and methods to reduce patients' opioid after surgery. Opioid dependence can manifest from prescription use, especially in patients who have never used opioids before.

The purpose of this study is to research the effect of different pain management education programs on pain control and opioid use after an anterior cruciate ligament reconstruction (ACLR) surgery. Specifically, does education directed at avoiding opioids unless in "unbearable pain" have any effect on reducing pain levels and opioid consumption in the early postoperative period compared to traditional pain management education?

Patients who agree to participate in this study will be assigned at random to two opioid education programs after ACLR. All patients will be given peri-operative pain management counseling and education. Patients in the experimental group will be instructed to avoid opioids unless in unbearable pain. Patients in the control group will be instructed to take opioid medication as needed for severe pain to "stay ahead" of the pain. Participants in both groups will be prescribed the exact same type and amount of postoperative medications.

Surveys will be sent electronically to patients twice per day for 2 weeks to monitor pain levels and the amount of opioid consumption. Also, patients will be asked to complete demographic and patient-reported outcome questionnaires after surgery. Patients will be involved in the study for 3 months.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • University of Maryland Rehabilitation and Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women aged 14 years and older
  2. All patients scheduled to undergo an ACLR with or without concomitant procedures such as arthroscopic cartilage procedures, meniscus repair or meniscectomy, and/or lateral extraarticular tenodesis (anterolateral ligament reconstruction)
  3. Willing to participate in a perioperative pain management education and counseling program
  4. Willing to track pain levels and opioid consumption through surveys administered via text
  5. Willing to receive a perioperative regional nerve block
  6. Language skills and cognitive ability required to participate in the study
  7. Provision of informed consent

Exclusion Criteria:

  1. Revision ACLR
  2. Concomitant open cartilage procedures or additional knee ligament repair or reconstruction
  3. Concomitant injury that would also influence pain management
  4. History of heroin use or opioid abuse requiring treatment
  5. If any previous ipsilateral knee surgery except for knee arthroscopy
  6. Preoperative Kellgren-Lawrence grade 3 and 4 on weightbearing radiographs
  7. An allergy to any of the study medications
  8. Previously enrolled in the CARE trial
  9. Anticipated problems with the patient returning for follow-up or accurate completion of survey
  10. If patient cannot reliably receive texts and use internet to complete surveys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opioid-Limiting Perioperative Pain Management Education and Counseling
Patients will be instructed to take oxycodone only as a last resort if the pain becomes unbearable. "The goal should be to take as little oxycodone as possible."
Behavioral: Perioperative Pain Management Education and Counseling
All patients will receive both verbal postoperative pain management education and counseling as well as a written handout. Multi-modality non-opioid methods of pain control will be thoroughly discussed.
Active Comparator: Traditional Perioperative Pain Management Education and Counseling
Patients will be instructed to take opioids as needed for severe pain to manage and "stay ahead" of the postoperative pain
Behavioral: Perioperative Pain Management Education and Counseling
All patients will receive both verbal postoperative pain management education and counseling as well as a written handout. Multi-modality non-opioid methods of pain control will be thoroughly discussed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: 3 months
The total morphine equivalents (TMEs) consumed by the patient after surgery
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Scale
Time Frame: Two weeks
Participants will record a Numeric Pain Scale (NPS) score every day on a scale of 0-10, where 0= no pain and 10= worst possible pain. Mean NPS values for each postoperative day will be compared between groups.
Two weeks
Patient Reported Outcomes - Satisfaction with social roles & activities
Time Frame: 2 weeks, 6 weeks, 3 months
Patient reported social satisfaction will be assessed after surgery using PROMIS Satisfaction with Social roles and Activities questionnaire
2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Physical Function
Time Frame: 2 weeks, 6 weeks, 3 months
Patient reported physical functioning will be assessed after surgery using PROMIS Physical Function questionnaire
2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Pain
Time Frame: 2 weeks, 6 weeks, 3 months
Patient reported pain will be assessed after surgery using PROMIS Pain Interference questionnaire
2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Fatigue
Time Frame: 2 weeks, 6 weeks, 3 months
Patient reported fatigue will be assessed after surgery using PROMIS Fatigue questionnaire
2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Depression
Time Frame: 2 weeks, 6 weeks, 3 months
Patient reported depression will be assessed after surgery using PROMIS Emotional Distress - Depression questionnaire
2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Anxiety
Time Frame: 2 weeks, 6 weeks, 3 months
Patient reported anxiety will be assessed after surgery using PROMIS Emotional Distress - Anxiety questionnaire
2 weeks, 6 weeks, 3 months
Opioid Prescription Refills
Time Frame: 3 months
The mean number of opioid prescription refills per patient will be compared between the two treatment groups.
3 months
Patient Satisfaction
Time Frame: 2 weeks, 6 weeks, and 3 months
Patient satisfaction will be assessed by the Surgical Satisfaction Survey (SSQ-8), with responses ranging from Very Satisfied to Very Unsatisfied.
2 weeks, 6 weeks, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Jonathan D. Packer, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00093883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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