Recruiting NCT06511232
Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraosseous Morphine.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: A Randomized Control Trial
Overview
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.
Interventions
- Drug Intraosseous Morphine
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
Primary outcome measures
- 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]
- Changes in Post-Operative Opioid Use [Time frame: 2 weeks postop]
- 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]
Secondary outcome measures (3)
- 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]
- 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]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Houston Methodist Research Institute — Houston
Identifiers
NCT: NCT06511232 · PRO00037918