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Intra-articular Local Anesthetic Injection and Hematoma Aspiration

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02951884
Enrollment
2
Registered
2016-11-01
Start date
2016-06-15
Completion date
2018-05-03
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Fractures

Keywords

Aspiration, Bupivacaine, Epinephrine, Marcaine, Pain, Shin Bone

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).

Interventions

PROCEDUREAspiration

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

DRUGBupivacaine

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

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

This study uses a single blind masking scheme

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scale (NRS) Pain Scores24 hoursTwenty-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

MeasureTime frameDescription
Supplemental Analgesia24 hoursTwenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from June 2016 through May 2018 (24 months) from the Orthopaedic Surgery and Rehabilitation Center at Loyola University Medical Center.

Participants by arm

ArmCount
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.
0
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
1
Control
Participants assigned to this arm receive no injection or aspiration therapy.
1
Total2

Baseline characteristics

CharacteristicAspiration With InjectionControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants1 Participants2 Participants
Region of Enrollment
United States
1 participants1 participants2 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
1 Participants1 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 10 / 1
other
Total, other adverse events
0 / 00 / 10 / 1
serious
Total, serious adverse events
0 / 00 / 10 / 1

Outcome results

Primary

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.

Time frame: 24 hours

Population: The analysis population comprises both participants who consented to participate in the trial

ArmMeasureValue (NUMBER)
Aspiration With InjectionNumerical Rating Scale (NRS) Pain Scores7 units on a scale
ControlNumerical Rating Scale (NRS) Pain Scores2 units on a scale
Secondary

Supplemental Analgesia

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

Time frame: 24 hours

Population: The analysis population comprises both participants who consented to participate in the trial

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AspirationSupplemental Analgesia0 Participants
Aspiration With InjectionSupplemental Analgesia0 Participants
ControlSupplemental Analgesia1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026