Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

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• Anterior Cruciate Ligament Injuries 512

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's planned enrollment of 84 is above the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Lead sponsor

The Methodist Hospital Research Institute is the lead sponsor of 157 studies on the registry; 60 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 15 (60%) have results posted.

Study arms

• Experimental
  Intraosseous Injection of Morphine

  The intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle during a standard ACL reconstruction.

  Drug: Intraosseous Morphine

• No intervention
  Standard of Care Morphine Administration

  The control group will receive the standard of care treatment, which is no IO injection during a standard ACL reconstruction.

Interventions

• DrugIntraosseous 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.

  Also known as: Duramorph, Astramorph PF, Infumorph

Primary outcomes

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

   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.

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

2. Changes in Post-Operative Opioid Use

   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.

   Time frame: 2 weeks postop

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

   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.

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

Secondary outcomes

1. Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey

   Patients will complete the KOOS, JR. Knee Survey to self-report their level of difficulty/pain (from none to extreme) certain movements have caused them. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

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

2. Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.

   Patients will complete the Tegner Activity Level Survey which will ask them to self-report their pre-operative and post-operative level of activity. The rating system scores a person's activity level between 0 and 10, where 0 is "sick leave or disability pension because of knee problems" and 10 is "participation in competitive sports such as soccer at a national or international elite level." As such, a higher score reflects better outcomes on this measure.

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

3. Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey

   The Lysholm Knee Survey will ask specific questions with a variety of responses to reflect movement-ability responses such as the use of a cane, the presence of a limp, squatting, climbing stairs, 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.

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