Clinical trial NCT04885231: Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction
Official title: Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Opioid Use
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 121
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center randomized control trial consisting of two groups - one control and one experimental.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 3 months
Secondary outcomes:
measure: Numeric Pain Scale
timeFrame: Two weeks
measure: Patient Reported Outcomes - Satisfaction with social roles & activities
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Patient Reported Outcomes - Physical Function
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Patient Reported Outcomes - Pain
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Patient Reported Outcomes - Fatigue
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Patient Reported Outcomes - Depression
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Patient Reported Outcomes - Anxiety
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Opioid Prescription Refills
timeFrame: 3 months
measure: Patient Satisfaction
timeFrame: 2 weeks, 6 weeks, and 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Rehabilitation and Orthopaedic Institute
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Jonathan D. Packer, MD
role: PRINCIPAL_INVESTIGATOR
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