Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction

NCT04885231 | Completed DMC

• 1 other identifier: HP-00093883
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  The total morphine equivalents (TMEs) consumed by the patient after surgery

  3 months

Secondary Outcomes (9)

• Numeric Pain Scale

  Two weeks

• Patient Reported Outcomes - Satisfaction with social roles & activities

  2 weeks, 6 weeks, 3 months

• Patient Reported Outcomes - Physical Function

  2 weeks, 6 weeks, 3 months

• Patient Reported Outcomes - Pain

  2 weeks, 6 weeks, 3 months

• Patient Reported Outcomes - Fatigue

  2 weeks, 6 weeks, 3 months

Study Arms (2)

Opioid-Limiting Perioperative Pain Management Education and Counseling

EXPERIMENTAL

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

Traditional Perioperative Pain Management Education and Counseling

ACTIVE COMPARATOR

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

Interventions

Perioperative Pain Management Education and Counseling BEHAVIORAL

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.

Opioid-Limiting Perioperative Pain Management Education and Counseling; Traditional Perioperative Pain Management Education and Counseling

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 14 years and older
• 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)
• Willing to participate in a perioperative pain management education and counseling program
• Willing to track pain levels and opioid consumption through surveys administered via text
• Willing to receive a perioperative regional nerve block
• Language skills and cognitive ability required to participate in the study
• Provision of informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Rehabilitation and Orthopaedic Institute

Baltimore, Maryland, 21207, United States

Location

Related Publications (19)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Counseling

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jonathan D. Packer, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single center randomized control trial consisting of two groups - one control and one experimental.

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 13, 2021
• Study Start: May 12, 2021
• Primary Completion: September 1, 2024
• Study Completion: April 29, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)