Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction
NCT Number: NCT06511232
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Anterior Cruciate Ligament Tear|Anterior Cruciate Ligament Injuries|Anterior Cruciate Ligament Rupture
Interventions: DRUG: Intraosseous Morphine
Sponsor: The Methodist Hospital Research Institute
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-19
Completion Date: 2029-07-31
Locations: Houston Methodist Research Institute, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Primary Outcome Measures: 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., 2 weeks postop, 6 weeks postop, 12 weeks postop|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., 2 weeks postop|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., 2 weeks postop, 6 weeks postop, 12 weeks postop
Secondary Outcome Measures: 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., Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop|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., Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop|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., 2 weeks postop, 6 weeks postop, 12 weeks postop