Actively Recruiting
Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: A Randomized Control Trial
Led by The Methodist Hospital Research Institute · Updated on 2026-04-09
84
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving morphine through an intraosseous (IO) injection into the tibial tubercle can reduce pain and the need for opioids after anterior cruciate ligament (ACL) reconstruction surgery. This study focuses on patients undergoing ACL reconstruction using a bone-patellar tendon-bone (BTB) autograft, an area not previously studied for this type of pain management. The trial is a randomized, single-masked study sponsored by The Methodist Hospital Research Institute, aiming to improve post-operative outcomes. Participants will be randomly assigned to one of two groups. The intervention group will receive a 10mg morphine injection mixed with saline directly into the bone during standard ACL reconstruction surgery. The control group will receive the usual care without the intraosseous injection. This treatment occurs during the surgery and compares the effects of the IO morphine to standard care alone. During the study, patients will report pain levels using a post-operative symptom journal and the Lysholm Knee Survey at 2, 6, and 12 weeks after surgery. Researchers will also track opioid use during the first 2 weeks post-surgery. Additional assessments will include knee range of motion and activity levels measured before surgery and at follow-up visits. The total participation covers these evaluations and monitoring of pain and function over 12 weeks to understand the impact of the IO morphine treatment.
CONDITIONS
Brief Title
Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ACL reconstruction with bone-to-bone (BTB) autograft
- Patients aged between 18 and 40 years old at the time of surgery
You will not qualify if you...
- Patients undergoing ACL reconstruction with any autograft or allograft other than BTB
- Patients younger than 18 years old or older than 40 years old
- Patients undergoing meniscal root repair or other repairs that change weight-bearing status
- Patients with a history of substance abuse
- Vulnerable populations
- Patients on chronic pain medication within the last 6 months
- Patients with a body mass index (BMI) of 35 or higher
- Allergy to morphine
- Unwillingness to participate
- Any additional reason the principal investigator deems reasonable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day
Participants undergo anterior cruciate ligament reconstruction surgery where the experimental group receives an intraosseous injection of morphine into the tibial tubercle during surgery, and the control group receives standard care without the injection.
1 surgical visit (in-person)
Duration - 12 weeks post-surgery
Participants are monitored for pain levels, opioid use, and knee function after surgery.
Visits at 2 weeks, 6 weeks, and 12 weeks postoperatively
Trial Site Locations
Total: 1 location
1
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Haley Goble, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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