Intraosseous Morphine in Primary TKA

NCT04388111 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro000023481
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Disease; Arthritis Knee; Pain, Acute

Keywords

Intraosseous; Total knee arthroplasty; Morphine

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain

  Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these scores were then averaged for the 14 day period and reported below.

  14 days

Secondary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative

  preoperative

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative

  two week postoperatively

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative

  8 weeks postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.

Intarosseous Morphine

EXPERIMENTAL

Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.

Drug: Morphine

Interventions

Morphine DRUG

10mg of Morphine delivered Intraosseously

Intarosseous Morphine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient gives informed consent to participate in the study
• Patient is undergoing a primary total knee arthroplasty.
• Age \> 18 and \<80 years old.

You may not qualify if:

• Patient lacks the capacity to consent to the research project (study will not utilize LAR signatures during the informed consent process)
• Weigh \< 100 pounds
• BMI \> 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Results Point of Contact

• Title: Research Coordinator
• Organization: Houston Methodist Hospital

tsullivan@houstonmethodist.org

346 238 1603

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patient, provider, and laboratory technicians are blinded to the patient's study group. Only the research coordinator and necessary OR support staff are aware of the patient's study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: May 5, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (1)