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Intra-articular Local Anesthetic Injection and Hematoma Aspiration

Primary Purpose

Tibial Fractures

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspiration
Bupivacaine
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Aspiration, Bupivacaine, Epinephrine, Marcaine, Pain, Shin Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Aspiration

Aspiration with injection

Control

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) Pain Scores
Twenty-four hours after injury, patients will self report their numerical rating scale (NRS) score. The NRS score ranges from 0 to 10 with higher scores indicating greater pain.

Secondary Outcome Measures

Supplemental Analgesia
Twenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.

Full Information

First Posted
October 28, 2016
Last Updated
August 15, 2018
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT02951884
Brief Title
Intra-articular Local Anesthetic Injection and Hematoma Aspiration
Official Title
The Effect of Intra-articular Local Anesthetic Injection and Hematoma Aspiration on Pain and Narcotic Analgesia Use Following Tibial Plateau Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped for feasibility (low enrollment)
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
Aspiration, Bupivacaine, Epinephrine, Marcaine, Pain, Shin Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive aspiration of the joint alone, receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or receive no injection or aspiration therapy
Masking
Participant
Masking Description
This study uses a single blind masking scheme
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspiration
Arm Type
Experimental
Arm Description
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.
Arm Title
Aspiration with injection
Arm Type
Experimental
Arm Description
Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants assigned to this arm receive no injection or aspiration therapy.
Intervention Type
Procedure
Intervention Name(s)
Aspiration
Intervention Description
A needle is placed into the knee joint and all of the blood that is in the joint is removed.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine, Exparel, Sensorcaine
Intervention Description
An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) Pain Scores
Description
Twenty-four hours after injury, patients will self report their numerical rating scale (NRS) score. The NRS score ranges from 0 to 10 with higher scores indicating greater pain.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Supplemental Analgesia
Description
Twenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Lack, MD
Organizational Affiliation
Loyola University Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers
Citations:
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19440710
Citation
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Intra-articular Local Anesthetic Injection and Hematoma Aspiration

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