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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02951884
• Other study ID #: 208755
• Status: Terminated
• Phase: Phase 4
• Start date: June 15, 2016
• Est. completion date: May 3, 2018

Study information

• Verified date: August 2018
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematoma
• Tibial Fractures

Intervention

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

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

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (13)

Badner NH, Bourne RB, Rorabeck CH, MacDonald SJ, Doyle JA. Intra-articular injection of bupivacaine in knee-replacement operations. Results of use for analgesia and for preemptive blockade. J Bone Joint Surg Am. 1996 May;78(5):734-8. — View Citation

Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. — View Citation

Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. — View Citation

Chalidis BE, Papadopoulos PP, Sachinis NC, Dimitriou CG. Aspiration alone versus aspiration and bupivacaine injection in the treatment of undisplaced radial head fractures: a prospective randomized study. J Shoulder Elbow Surg. 2009 Sep-Oct;18(5):676-9. doi: 10.1016/j.jse.2009.04.003. Epub 2009 May 31. — View Citation

Ditsios KT, Stavridis SI, Christodoulou AG. The effect of haematoma aspiration on intra-articular pressure and pain relief following Mason I radial head fractures. Injury. 2011 Apr;42(4):362-5. doi: 10.1016/j.injury.2010.09.003. Epub 2010 Oct 8. — View Citation

Franceschi F, Rizzello G, Cataldo R, Denaro V. Comparison of morphine and ropivacaine following knee arthroscopy. Arthroscopy. 2001 May;17(5):477-80. — View Citation

Heard SO, Edwards WT, Ferrari D, Hanna D, Wong PD, Liland A, Willock MM. Analgesic effect of intraarticular bupivacaine or morphine after arthroscopic knee surgery: a randomized, prospective, double-blind study. Anesth Analg. 1992 Jun;74(6):822-6. — View Citation

Jaureguito JW, Wilcox JF, Cohn SJ, Thisted RA, Reider B. A comparison of intraarticular morphine and bupivacaine for pain control after outpatient knee arthroscopy. A prospective, randomized, double-blinded study. Am J Sports Med. 1995 May-Jun;23(3):350-3. — View Citation

Koval KJ, Helfet DL. Tibial Plateau Fractures: Evaluation and Treatment. J Am Acad Orthop Surg. 1995 Mar;3(2):86-94. — View Citation

Manidakis N, Dosani A, Dimitriou R, Stengel D, Matthews S, Giannoudis P. Tibial plateau fractures: functional outcome and incidence of osteoarthritis in 125 cases. Int Orthop. 2010 Apr;34(4):565-70. doi: 10.1007/s00264-009-0790-5. Epub 2009 May 14. — View Citation

Perdreau A, Joudet T. Efficacy of multimodal analgesia injection combined with corticosteroids after arthroscopic rotator cuff repair. Orthop Traumatol Surg Res. 2015 Dec;101(8 Suppl):S337-45. doi: 10.1016/j.otsr.2015.09.006. Epub 2015 Nov 10. — View Citation

Stein C, Comisel K, Haimerl E, Yassouridis A, Lehrberger K, Herz A, Peter K. Analgesic effect of intraarticular morphine after arthroscopic knee surgery. N Engl J Med. 1991 Oct 17;325(16):1123-6. — View Citation

White BJ, Walsh M, Egol KA, Tejwani NC. Intra-articular block compared with conscious sedation for closed reduction of ankle fracture-dislocations. A prospective randomized trial. J Bone Joint Surg Am. 2008 Apr;90(4):731-4. doi: 10.2106/JBJS.G.00733. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours
Secondary	Supplemental Analgesia	Twenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.	24 hours