Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction

Not Applicable

Completed

• Conditions: Pain, Postoperative; Opioid Use
• Interventions: Behavioral: Perioperative Pain Management Education and Counseling

• Registration Number: NCT04885231
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-07
• Study Start: 2021-05-12
• Study First Posted: 2021-05-13
• Primary Completion: 2024-09-01
• Status Verified: 2025-04
• Study Completion: 2025-04-29
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Perioperative Pain Management Education and Counseling	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
Opioid-Limiting Perioperative Pain Management Education and Counseling	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."

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	3 months	The total morphine equivalents (TMEs) consumed by the patient after surgery

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Scale	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.
Patient Reported Outcomes - Satisfaction with social roles & activities	2 weeks, 6 weeks, 3 months	Patient reported social satisfaction will be assessed after surgery using PROMIS Satisfaction with Social roles and Activities questionnaire
Patient Reported Outcomes - Physical Function	2 weeks, 6 weeks, 3 months	Patient reported physical functioning will be assessed after surgery using PROMIS Physical Function questionnaire
Patient Reported Outcomes - Pain	2 weeks, 6 weeks, 3 months	Patient reported pain will be assessed after surgery using PROMIS Pain Interference questionnaire
Patient Reported Outcomes - Depression	2 weeks, 6 weeks, 3 months	Patient reported depression will be assessed after surgery using PROMIS Emotional Distress - Depression questionnaire
Patient Reported Outcomes - Fatigue	2 weeks, 6 weeks, 3 months	Patient reported fatigue will be assessed after surgery using PROMIS Fatigue questionnaire
Opioid Prescription Refills	3 months	The mean number of opioid prescription refills per patient will be compared between the two treatment groups.
Patient Satisfaction	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.
Patient Reported Outcomes - Anxiety	2 weeks, 6 weeks, 3 months	Patient reported anxiety will be assessed after surgery using PROMIS Emotional Distress - Anxiety questionnaire

Trial Locations

Locations (1)

University of Maryland Rehabilitation and Orthopaedic Institute; 🇺🇸 Baltimore, Maryland, United States