Phase 4
N=65
Intraosseous Morphine in Primary TKA
Knee Disease · Arthritis Knee · Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT04388111 ↗Enrolled (actual)
65
Serious AEs
4.2%
Results posted
Sep 2024
Primary outcome: Primary: Post-operative Pain — 4.29; 3.57 visual analog pain scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain |
4.29; 3.57 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative |
52.0; 51.4 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative |
64.0; 71.5 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative |
64.0; 71.5 | — |
Summary
The research team wants to investigate if an intraosseous injection (directly into the bone marrow) of morphine during primary total knee replacement helps with post-operative pain following primary total knee replacement surgery. For this study patients will either be randomized into one of two groups: Group 1: Receives an intraosseous injection of morphine (mixed with standard antibiotics) during their primary total knee replacement or Group 2: Serves as the control group and only receives an intraosseous injection of antibioitics during their total knee replacement. The research team will have patients fill out a symptom journal for two weeks following their surgery to measure pain levels and pain medication consumed throughout the day as well as nausea and other symptoms. Additionally, the research team will take blood samples both intraoperatively and post-operatively (10 hours post-op) to measure the level of inflammatory markers as well as morphine.
Eligibility Criteria
Inclusion Criteria
- Patient gives informed consent to participate in the study
- Patient is undergoing a primary total knee arthroplasty.
- Age > 18 and 35
- Pregnancy or suspected pregnancy
- Past medical history of opioid addiction.
- Established hypersensitivity (ie allergy) to morphine.
- Acute or chronic liver disease for example cirrhosis.
- Use of any narcotics 5 days before surgery (opioids, hydrocodone, morphine, hydromorphone, fentanyl, etc).
- Undergoing bilateral total knee replacement, revision total knee arthroplasty, or any additional procedure outside of a primary total knee arthroplasty.
- Unable to get general and spinal anesthesia.
Data sourced from ClinicalTrials.gov (NCT04388111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.