Recruiting

Morphine

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06511232

Conditions

Anterior Cruciate Ligament Tear

Anterior Cruciate Ligament Injuries

Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Intraosseous Morphine

Study Details

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.

Conditions

Anterior Cruciate Ligament Tear

Anterior Cruciate Ligament Injuries

Anterior Cruciate Ligament Rupture

Study ID

NCT06511232

Start date

Aug 19, 2024

Status verified date

Apr, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Haley Goble, MHA

713-441-3930hmgoble@houstonmethodist.org

Locations

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-04-09.