Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction
NCT ID: NCT06511232
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
84 participants
INTERVENTIONAL
2024-08-19
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intraosseous Morphine in Primary TKA
NCT04388111
Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
NCT06630520
ACL-R Opioid Sparing Study
NCT06561035
Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
NCT03818932
Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain
NCT03643822
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intraosseous Injection of Morphine
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.
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 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.
Standard of Care Morphine Administration
The control group will receive the standard of care treatment, which is no IO injection during a standard ACL reconstruction.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged between 18-40 years old at the time of surgery
Exclusion Criteria
* 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
18 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Methodist Hospital Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert A. Jack
Assistant Professor of Clinical Orthopedic Surgery, Academic Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Jack, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Houston Methodist Research Institute
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Haley Goble
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO00037918
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.