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NCT Number: NCT06511232

Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Haley Goble

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Intraosseous Morphine

Drug

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.

Other names: 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.

    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.

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Goble, MHA

CONTACT

[email protected]

713-441-3930

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jul 19, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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