Intra-articular Local Anesthetic Injection and Hematoma Aspiration

NCT ID: NCT02951884

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2018-05-03

Brief 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.

Detailed 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).

Conditions

Tibial Fractures

Study Design

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

Study Groups

Aspiration

Participants assigned to this arm 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.

Group Type: EXPERIMENTAL

Aspiration

Intervention Type: PROCEDURE

A needle is placed into the knee joint and all of the blood that is in the joint is removed.

Aspiration with injection

Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine

Group Type: EXPERIMENTAL

Aspiration

Intervention Type: PROCEDURE

A needle is placed into the knee joint and all of the blood that is in the joint is removed.

Bupivacaine

Intervention Type: DRUG

An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine

Control

Participants assigned to this arm receive no injection or aspiration therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aspiration

A needle is placed into the knee joint and all of the blood that is in the joint is removed.

Intervention Type: PROCEDURE

Bupivacaine

An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine

Intervention Type: DRUG

Other Intervention Names

Marcaine; Exparel; Sensorcaine

Eligibility Criteria

Inclusion Criteria

• Patients with isolated tibial plateau fractures aged 18 years and older
• Patients with tibial plateau fractures and associated soft tissue complaints about the knee, not associated with a fracture outside of the tibial plateau
• Patients with bilateral tibial plateau fractures and no other noted fractures

Exclusion Criteria

• Any patient that does not wish to participate in the study or is unable to give consent at the initial encounter
• Patients under 18 years old
• Pregnant patients
• Patients who are unable to understand the study procedures
• Incarcerated patients
• History of allergic reaction to local anesthetics
• Emergent conditions requiring operations or airway protection
• Polytrauma patients
• Patients presenting for care greater than 24 hours following their injury.

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

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

William Lack

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Lack, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

208755

Identifier Type: -

Identifier Source: org_study_id