University of Maryland Rehabilitation and Orthopaedic Institute
Baltimore, Maryland, 21207, United States
NCT Number: NCT04885231
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.
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Notify Me14 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21207, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
The total morphine equivalents (TMEs) consumed by the patient after surgery
Time frame: 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.
Time frame: 2 weeks, 6 weeks, 3 months
Patient reported social satisfaction will be assessed after surgery using PROMIS Satisfaction with Social roles and Activities questionnaire
Time frame: 2 weeks, 6 weeks, 3 months
Patient reported physical functioning will be assessed after surgery using PROMIS Physical Function questionnaire
Time frame: 2 weeks, 6 weeks, 3 months
Patient reported pain will be assessed after surgery using PROMIS Pain Interference questionnaire
Time frame: 2 weeks, 6 weeks, 3 months
Patient reported fatigue will be assessed after surgery using PROMIS Fatigue questionnaire
Time frame: 2 weeks, 6 weeks, 3 months
Patient reported depression will be assessed after surgery using PROMIS Emotional Distress - Depression questionnaire
Time frame: 2 weeks, 6 weeks, 3 months
Patient reported anxiety will be assessed after surgery using PROMIS Emotional Distress - Anxiety questionnaire
Time frame: 3 months
The mean number of opioid prescription refills per patient will be compared between the two treatment groups.
Time frame: 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.
University of Maryland, Baltimore
Other
Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Acronym: CARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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