Intra-articular Local Anesthetic Injection and Hematoma Aspiration

Tibial Fractures Clinical Trial

Official title: The Effect of Intra-articular Local Anesthetic Injection and Hematoma Aspiration on Pain and Narcotic Analgesia Use Following Tibial Plateau Fractures

Status Terminated

Clinical Trial Summary

The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.

Clinical Trial Description

We propose to study tibial plateau fractures treated at our institution for which we have fracture data, treated with open reduction internal fixation (ORIF) procedures or treated non-operatively. Patients will be identified based on the classification of their injury, that being tibial plateau fracture; we will seek to sub-classify each patient based on the Shatzker classification of tibial plateau fractures and using knee osteoarthritis (OA) classification as our prospective study will be based on both tibial plateau fractures as a whole and their sub-classification: Lateral tibial plateau fracture without depression (I), lateral tibial plateau fracture with depression (II), compression fracture of the lateral (IIIA) or central (IIIB) tibial plateau, medial tibial plateau fracture (IV), bicondylar tibial plateau fracture (V), and tibial plateau fracture with diaphyseal discontinuity (VI). It is important for our prospective study to classify each fracture pattern as they generally differ in energy of injury and thus may affect pain management or need for narcotic pain medications and also potentially affect functional outcomes.

Following consent for participation in the study, patients will be blinded to initial management of the tibial plateau fracture with either: Aspiration of the joint alone, aspiration of the knee joint and injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or no injection or aspiration therapy for a control arm. Using the block randomization list, the patient will be randomized at the time of consent for participation. For the sake of consistency, all participating treating physicians (orthopaedic on-call residents) will be trained on Sawbones Fully Encased Knee Joint with Patella and Ligaments for a standardized aspiration and injection technique.

For the patients randomized into the treatment arms, the knee will be held in 15-30 degrees short of full extension and fully prepped using chlorhexidine wipes in a centrifugal manner. An 18 gauge spinal needle will be introduced into the superolateral aspect of the knee (if the knee is too edematous, an inferolateral or inferomedial approach may be appropriate). We will aspirate the knee with a 60cc syringe until we are unable to draw out more fluid and record the volume on a case record form. Subsequently, we will remove the syringe from the needle connection, leaving the 18 gauge needle in place. Then we will draw up 30cc of 0.5% bupivacaine with 1:200,000 epinephrine (Marcaine) with .18-gauge needle into the second 60cc syringe. Subsequently, we will place the filled syringe on the 18 gauge needle already in the knee and inject. Then we will remove the needle-syringe construct and place a bandage over the injection site.

The patient's initial numerical rating scale (NRS) score will be recorded immediately. Subsequent visual analogue scale (VAS) scores will be recorded at 5 minutes after intervention and at hours 2, 4, 6, 8, 12, and 24 after initial work-up of the patient. Patients treated as an outpatient will record these values themselves. Patients will be directed to bring the completed form with them to their regular clinic follow-up visit. Additionally, supplemental analgesia requirements will be recorded upon administration and will be converted to morphine equivalent units for analysis. All patients admitted to the orthopedic service will be placed on patient-controlled analgesic (PCA) morphine, where the dose is determined by the weight of the patient. All other patients (those admitted to other services) will have analgesia converted to Opioid Morphine Equivalents (OMEs). ;

Related Conditions & MeSH terms

• Hematoma
• Tibial Fractures

• NCT number: NCT02951884
• Study type: Interventional
• Source: Loyola University
• Status: Terminated
• Phase: Phase 4
• Start date: June 15, 2016
• Completion date: May 3, 2018