ACL-R Opioid Sparing Study (NCT06561035) | Clinical Trial Compass
By InvitationPhase 3
ACL-R Opioid Sparing Study
United States56 participantsStarted 2024-09-01
Plain-language summary
This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).
Who can participate
Age range
14 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 14-85 years of age.
* Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty.
* Patients weigh at least 90lbs at time of enrollment.
* Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River).
* Willing and able to provide written informed consent.
* Willing and able to cooperate with postoperative therapy.
* Speak and read fluent English.
Exclusion Criteria:
* Multiligament knee reconstruction.
* Pre-injury opioid consumption.
* Substance abuse disorder (illicit drug abuse, alcoholism, etc).
* Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient).
* Chronic pain syndrome.
* Renal disease.
* Currently taking selective serotonin reuptake inhibitors and/or serotonin and norepinephrine reuptake inhibitors.
* Known sensitivity, allergy, or intolerance to medications within protocols.
* History of diabetes.
* Currently taking glucagon-like peptide 1 agonist.
* Female patient who is pregnant on day of surgery or becomes pregnant during study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale
Timeframe: Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.
2
Oral morphine equivalent
Timeframe: daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.