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

121 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan D. Packer, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+