Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06511232
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Rupture
  • Anterior Cruciate Ligament Tear

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Intraosseous Morphine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 19, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Research InstituteHoustonTexas77030
Haley Goble

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Houston Methodist Research Institute· Houston, TX

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