Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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 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 names:
    • Duramorph
    • Astramorph PF
    • Infumorph
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.

Recruiting Locations

Houston Methodist Research Institute
Houston, Texas 77030
Contact:
Haley Goble

More Details

Status
Recruiting
Sponsor
The Methodist Hospital Research Institute

Study Contact

Haley Goble, MHA
713-441-3930
hmgoble@houstonmethodist.org