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

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Pain, Postoperative; Opioid Use

Treatments: Behavioral: Perioperative Pain Management Education and Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04885231

HP-00093883

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Opioid-Limiting Perioperative Pain Management Education and Counseling

Experimental group

Description:

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."

Treatment:

Behavioral: Perioperative Pain Management Education and Counseling

Traditional Perioperative Pain Management Education and Counseling

Active Comparator group

Description:

Patients will be instructed to take opioids as needed for severe pain to manage and "stay ahead" of the postoperative pain

Treatment:

Behavioral: Perioperative Pain Management Education and Counseling