Clinical trial NCT06511232: Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction
Official title: Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-blind randomized controlled trial with two arms, 1) Intervention and 2) control. The intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle. The control group will receive the standard of care treatment, which is no IO injection. The subjects' post-operative pain levels, pain medication consumption, side effects to pain medications, and range of motion will be recorded for 14 days following surgery. Additionally, patient reported outcomes will be tracked via surveys prior to surgery and 2, 6, and 12-weeks following surgery.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.
timeFrame: 2 weeks postop, 6 weeks postop, 12 weeks postop
measure: Changes in Post-Operative Opioid Use
timeFrame: 2 weeks postop
measure: Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey
timeFrame: 2 weeks postop, 6 weeks postop, 12 weeks postop
Secondary outcomes:
measure: Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey
timeFrame: Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop
measure: Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.
timeFrame: Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop
measure: Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey
timeFrame: 2 weeks postop, 6 weeks postop, 12 weeks postop
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Robert Jack, MD
role: PRINCIPAL_INVESTIGATOR
References: