Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

NCT06511232 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PRO00037918
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (3)

• Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.

  The study will measure patient-reported levels of pain on a daily basis (for a total of two weeks) with a symptom journal, which will ask patients to report on a variety of pain-related outcomes including levels of pain throughout different times of day, levels of nausea throughout different times of the day, and what pain medication(s) they are taking and at what time.

  2 weeks postop, 6 weeks postop, 12 weeks postop

• Changes in Post-Operative Opioid Use

  To examine if the use of IO morphine will result in different levels of post-operative opioid use compared to SOC administration of morphine. This outcome will be assessed utilizing the daily symptom journal which will ask patients to complete daily logs of the pain medication that they take (what kind, what dose, when they took it, etc.) for two weeks following their operation.

  2 weeks postop

• Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey

  Participants will be asked to complete the Lysholm Knee survey at 2, 6, and 12 weeks postop which will assess patient progress following surgery such as pain, swelling, climbing stairs, using a crutch, etc. The Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.

  2 weeks postop, 6 weeks postop, 12 weeks postop

Secondary Outcomes (3)

• Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey

  Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop

• Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.

  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

  2 weeks postop, 6 weeks postop, 12 weeks postop

Study Arms (2)

Intraosseous Injection of Morphine

EXPERIMENTAL

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.

Drug: Intraosseous Morphine

Standard of Care Morphine Administration

NO INTERVENTION

The control group will receive the standard of care treatment, which is no IO injection during a standard ACL reconstruction.

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.

Also known as: Duramorph, Astramorph PF, Infumorph

Intraosseous Injection of Morphine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Morphine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Robert Jack, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Goble, MHA

CONTACT

713-441-3930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Orthopedic Surgery, Academic Institute

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 19, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)