Impact of Opioid Avoidance Protocol for ACL Reconstruction (NCT06340932) | Clinical Trial Compass
CompletedNot Applicable
Impact of Opioid Avoidance Protocol for ACL Reconstruction
United States32 participantsStarted 2024-04-27
Plain-language summary
This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for Anterior Cruciate Ligament Reconstruction (ACLR) postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change.
The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in milligrams of morphine equivalent (MME) from postoperative day (POD) 0 to 7 after ACLR compared to the current standard of care pain management protocol.
Secondary objectives are to:
* evaluate the effects of an opioid avoidance protocol on the daily average numeric rating scale (NRS) pain scores from POD0-7
* evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7
* evaluate the ability to recover opioid free through 7, 30, and 60 days
* evaluate the quality of recovery 15 (QoR-15) scores on POD2
* assess the number of opioid prescriptions required by patients in the 60 day recover period
* assess Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and symptom scales at 8 weeks post-operatively between groups.
Who can participate
Age range
15 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:
* Patients aged 15 years or older at screening.
* Primary diagnosis of ACL injury as evidenced by MRI or similar imaging study and are scheduled to undergo ACLR with or without meniscal repair/meniscectomy
* Non-pregnant patients with verbal confirmation that they are not planning to become pregnant during the study period.
i. Female subjects must have a confirmatory negative pregnancy test as part of the routine pre-operative laboratory testing ii. Subjects must endorse a plan to utilize contraceptives (condoms, hormonal birth control, IUD, etc.) for any sexual activity during the study period.
* English speaking patients
* Provision of informed consent with ability to adhere to the study visit schedule and complete all study assessments.
Exclusion Criteria:
* Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
* History of contralateral ACL repair within 1 year of screening
* Multi-ligament injury requiring reconstruction
* Inability to return to the study doctor's clinic for postoperative visits
* Pregnant or trying to become pregnant
* Breastfeeding
* Have a severe chronic pain condition that in the opinion of the study doctor may impact post-surgical outcomes of analgesic and opioid usage (i.e., fibromyalgia, cancer, sickle cell disease)
* Have a known contraindication to the iovera° device, including any of the following:
i. Cryoglobulinemia (presence of abnormal proteins in the blood that thicken in c…
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.