Counseling and Education for Post-Knee Surgery Pain

(CARE Trial)

Overseen By Heather Phipps, MPS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Revision ACLR, Heroin use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether changing guidance on opioid use after knee surgery can reduce opioid consumption and improve pain control. Participants will be divided into two groups: one will take opioids only for unbearable pain, while the other will take them as needed for severe pain. The goal is to determine if using fewer opioids leads to better outcomes. Ideal candidates are those scheduled for ACL reconstruction surgery and open to trying a new pain management approach through Perioperative Pain Management Education and Counseling. Participants must be willing to track their pain levels and opioid use through regular surveys. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management strategies that could benefit future patients.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, all patients will receive the same postoperative medications, so it's best to discuss your current medications with the trial team.

What prior data suggests that this pain management education and counseling program is safe?

Research has shown that using fewer opioids for pain management after surgery can be safe. In a recent study, patients who used opioids only as a last option consumed fewer opioids than those who followed traditional instructions. This suggests that this method does not increase pain and is well-tolerated.

Another study found that educating and counseling patients about opioid use helped reduce their opioid consumption. This approach appears to manage pain effectively without heavily relying on opioids, which can cause side effects if overused.

Overall, evidence supports that educating and counseling patients to limit opioid use is a safe way to manage pain after surgery. This method focuses on using fewer opioids, potentially reducing the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage pain after knee surgery with minimal reliance on opioids. Traditional approaches often involve taking opioids as needed to control severe pain, but the experimental approach in this trial encourages patients to use opioids like oxycodone only as a last resort. This shift aims to reduce opioid consumption, potentially lowering the risk of addiction and side effects. By focusing on education and counseling, this method could empower patients to manage their pain more effectively and safely.

What evidence suggests that this counseling and education program is effective for post-knee surgery pain management?

Research has shown that patients who learned to limit opioid use for pain management after ACL surgery used fewer opioids. In this trial, one group will receive Opioid-Limiting Perioperative Pain Management Education and Counseling, which advises taking opioids only when pain is unbearable, not merely severe. Studies have found that this approach reduces opioid use without increasing pain levels. The education helps patients manage pain more effectively and rely less on opioids. Overall, this strategy can lead to better pain control and reduced opioid use. ^{2 3 4 6 7}

Who Is on the Research Team?

Jonathan D. Packer, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

Adults and teens aged 14+ who are about to have ACL reconstruction surgery can join. They must be able to receive texts, use the internet for surveys, understand study instructions, and consent to participate. Excluded are those with prior similar surgeries, severe knee arthritis, drug abuse history, or allergies to study meds.

Inclusion Criteria

Willing to track pain levels and opioid consumption through surveys administered via text

Language skills and cognitive ability required to participate in the study

Provision of informed consent

Exclusion Criteria

Previous surgery to repair the anterior cruciate ligament (ACLR).

You are currently having surgery on your knee or getting a knee ligament repair.

You have another injury that could affect how we manage your pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive perioperative pain management education and counseling, with instructions on opioid use based on group assignment

2 weeks

Daily electronic surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, opioid consumption, and patient-reported outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Perioperative Pain Management Education and Counseling

Trial Overview The trial tests if a special counseling program on pain management reduces opioid use after ACL surgery compared to standard advice. Both groups get the same pain meds but different usage instructions. Participants will report their pain levels and opioid intake twice daily for two weeks.

How Is the Trial Designed?

Group I: Opioid-Limiting Perioperative Pain Management Education and Counseling Experimental Treatment 1 Intervention

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."

Group II: Traditional Perioperative Pain Management Education and Counseling Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10732618/

The Impact of Preoperative Patient Education on ... Gaps in preoperative education regarding postoperative pain and opioid use may lead to increased patient anxiety and persistent postoperative opioid use.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399118306554

Patient education and engagement in postoperative pain ... The primary outcome was total opioid dosage in morphine milligram equivalents (MME) for the first two postoperative days. Secondary outcomes included daily ...

3. rheumatologyadvisor.com rheumatologyadvisor.com/news/perioperative-counseling-reduces-opioid-use-after-acl-reconstruction-surgery/

Perioperative Counseling Reduces Opioid Use After ACL ... Patients who received opioid-limiting perioperative pain management education to take opioids only as a last resort consumed fewer opioids.

4. newswise.com newswise.com/pdf_docs/175330726471604_Perioperative%20Opioid%20Counseling%20for%20Patients%20Undergoing%20Anterior%20Cruciate%20Ligament%20Reconstruction%20(2).pdf

Perioperative Opioid Counseling for Patients Undergoing ... Conclusions: Among patients undergoing ACL reconstruction surgery, opioid-limiting pain management education and counseling reduced opioid consumption with no ...

5. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/37496-the-ramifications-of-opioid-utilization-and-outcomes-of-alternative-pain-control-strategies-for-total-knee-arthroplasties

The Ramifications of Opioid Utilization and Outcomes of ... Patient education and engagement in postoperative pain management decreases opioid use following knee replacement surgery. Patient Educ ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40440513/

Perioperative Opioid Counseling for Patients Undergoing ... This study evaluated the impact of opioid-limiting perioperative pain management education and counseling on postoperative opioid consumption.

7. mdpi.com mdpi.com/2227-9032/9/3/333

Perioperative Pain Management and Opioid Stewardship Patients on long-term opioid therapies prior to surgery experience increased rates of postoperative complications in addition to higher rates of persistent ...