Intraosseous Morphine in Primary TKA

The Methodist Hospital Research Institute (TMHRI) logo

The Methodist Hospital Research Institute (TMHRI)

Status and phase

Completed
Phase 4

Conditions

Arthritis Knee
Pain, Acute
Knee Disease

Treatments

Drug: Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT04388111
Pro000023481

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 2 patient groups

Control Group
No Intervention group
Description:
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 group
Description:
Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.
Treatment:
Drug: Morphine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems