Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

DRUG

Intraosseous Morphine

More recently, intraosseous infusion of analgesics and antibiotics has gained traction in the total joint arthroplasty literature. In knee arthroplasty patients, the combination of a spine and adductor canal block with an intraosseous infusion of morphine into the tibial tubercle prior to incision yielded lower pain in the immediate postoperative period and at 2 weeks, less pain medication use, and significantly better patient-reported outcomes while also reducing systemic opioid exposure in the early postoperative period compared to the spine and adductor block alone.3 No study to date in the available literature has evaluated the efficacy of intraosseous morphine infusion in managing acute postoperative pain in patients undergoing ACL reconstruction with bone-patellar tendon-bone autograft, so that is the intended evaluation point with this project.

Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.

Time frame: 2 weeks postop, 6 weeks postop, 12 weeks postop

The study will measure patient-reported levels of pain on a daily basis (for a total of two weeks) with a symptom journal, which will ask patients to report on a variety of pain-related outcomes including levels of pain throughout different times of day, levels of nausea throughout different times of the day, and what pain medication(s) they are taking and at what time.

Changes in Post-Operative Opioid Use

Time frame: 2 weeks postop

To examine if the use of IO morphine will result in different levels of post-operative opioid use compared to SOC administration of morphine. This outcome will be assessed utilizing the daily symptom journal which will ask patients to complete daily logs of the pain medication that they take (what kind, what dose, when they took it, etc.) for two weeks following their operation.

Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey

Time frame: 2 weeks postop, 6 weeks postop, 12 weeks postop

Participants will be asked to complete the Lysholm Knee survey at 2, 6, and 12 weeks postop which will assess patient progress following surgery such as pain, swelling, climbing stairs, using a crutch, etc. The Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.

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A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

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Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.