Intraosseous Morphine in Primary TKA

NCT ID: NCT04388111

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2021-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intarosseous Morphine

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

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

10mg of Morphine delivered Intraosseously

Interventions

Morphine

10mg of Morphine delivered Intraosseously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Kwan Park, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro000023481

Identifier Type: -

Identifier Source: org_study_id