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Opioid

Intraosseous Morphine for ACL Injury

Phase 4
Recruiting
Led By Robert Jack, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients younger than 18 years old or older than 40 years old
Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks postop, 6 weeks postop, 12 weeks postop
Awards & highlights

Summary

"This trial aims to investigate whether using morphine directly into the bone can reduce pain and the need for painkillers after surgery for ACL reconstruction."

Who is the study for?
This trial is for individuals undergoing anterior cruciate ligament (ACL) reconstruction. Specific eligibility criteria are not provided, but typically participants would need to be in good health aside from their ACL injury and able to comply with the study requirements.
What is being tested?
The study is testing whether giving morphine directly into the bone (intraosseous) can reduce pain and lessen the need for other opioids after ACL surgery.
What are the potential side effects?
While specific side effects of intraosseous morphine aren't listed, common ones may include nausea, vomiting, dizziness, itching, or respiratory depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ACL surgery will be done by an approved surgeon using my own bone graft.
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am either younger than 18 or older than 40.
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I am having ACL surgery with a graft type that is not bone-tendon-bone.
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I am having surgery that will affect how I can put weight on my leg.
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My BMI is 35 or higher.
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I am not willing to participate in the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks postop, 6 weeks postop, 12 weeks postop
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks postop, 6 weeks postop, 12 weeks postop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Post-Operative Opioid Use
Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.
Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey
Secondary study objectives
Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.
Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR. Knee Survey
Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey

Side effects data

From 2015 Phase 4 trial • 84 Patients • NCT02009722
52%
Moderate to Severe Pruritus
40%
Moderate to Severe Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intrathecal Morphine
Intrathecal Hydromorphone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intraosseous Injection of MorphineExperimental Treatment1 Intervention
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.
Group II: Standard of Care Morphine AdministrationActive Control1 Intervention
The control group will receive the standard of care treatment, which is no IO injection during a standard ACL reconstruction.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
281 Previous Clinical Trials
81,522 Total Patients Enrolled
Robert Jack, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
~56 spots leftby Jul 2027
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