Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

Phase 4

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture
• Interventions: Drug: Intraosseous Morphine

• Registration Number: NCT06511232
• Lead Sponsor: The Methodist Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Status Verified: 2024-08
• Study Start: 2024-08-19
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Patients of the IRB approved surgeon(s) undergoing ACL reconstruction with bone-to-bone (BTB) autograft
• Patients aged between 18-40 years old at the time of surgery

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Exclusion Criteria

• Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB
• Patients younger than 18 years old or older than 40 years old
• Patients undergoing meniscal root repair or any other repair that changes their weight-bearing status
• Patients with a history of substance abuse
• Vulnerable populations
• Patients on chronic pain medication within the last 6 months
• BMI >/= 35
• Allergy to morphine
• Unwilling to participate
• Any additional reason the PI deems reasonable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraosseous Injection of Morphine	Intraosseous 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey	Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop	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.
Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.	Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop	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.
Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey	2 weeks postop, 6 weeks postop, 12 weeks postop	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.

Trial Locations

Locations (1)

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States