Clinical Trial: Effect of Local Anesthetic Injection and Hemarthrosis Aspiration on Pain and Narcotic/Opioid Analgesia Use-Tibial Plateau Fractures

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

Brief Summary: This study will evaluate pain level experienced by patients who have a break of the top of their shinbone and have either blood removed from the joint alone or have blood removed and medicine injected into the joint.

Detailed Summary:

Patients will be randomly assigned to one of three groups.

Group 1 will receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee after fractures.

Group 2 will receive aspiration of the knee joint (the same as Group 1) and will receive an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, which is a local anesthetic commonly used for the numbing of skin.

Group 3 will receive no injection or aspiration therapy; instead will be treated as normally treated for this type of fracture.

After the aspiration or the aspiration and injection:

Initial pain score will be recorded immediately. Subsequent pain scores will be recorded at time points 0 (5 minutes after intervention), 2, 4, 6, 8, 12, 24 hours after initial work-up. If patient treated as an outpatient then patent will be asked to self-record pain scores on a scale of 0-10 (0= no pain and 10= worst pain you have ever had). In all cases patients will be managed appropriately for the injury.


Sponsor: Loyola University

Current Primary Outcome:

  • Numerical Rating Scale (NRS) pain scores [ Time Frame: Immediately - at time of patient initial work-up ]
    NRS score recorded immediately with Subsequent Visual Analog Scale (VAS) at time points identified in following outcomes.
  • Visual Analog Scale (VAS) [ Time Frame: 5 minutes after intervention ]
  • Visual Analog Scale (VAS) [ Time Frame: 2 hours after intervention ]
  • Visual Analog Scale (VAS) [ Time Frame: 4 hours after intervention ]
  • Visual Analog Scale (VAS) [ Time Frame: 6 hours after intervention ]
  • Visual Analog Scale (VAS) [ Time Frame: 8 hours after intervention ]
  • Visual Analog Scale (VAS) [ Time Frame: 12 hours after intervention ]
  • Visual Analog Scale (VAS) [ Time Frame: 24 hours after intervention ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Use of supplemental analgesia (pain medicine) [ Time Frame: During the 24 hour period post intervention ]

Administration of supplemental analgesia will be recorded and converted to morphine equivalent units for analysis.


Original Secondary Outcome: Same as current

Information By: Loyola University

Dates:
Date Received: October 28, 2016
Date Started: November 2016
Date Completion: December 2017
Last Updated: October 29, 2016
Last Verified: October 2016