Intra-articular Local Anesthetic Injection and Hematoma Aspiration

NCT02951884 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 208755
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Fractures

Keywords

Aspiration; Bupivacaine; Epinephrine; Marcaine; Pain; Shin Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Supplemental Analgesia

  24 hours

Study Arms (3)

Aspiration

EXPERIMENTAL

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.

Procedure: Aspiration

Aspiration with injection

EXPERIMENTAL

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

Procedure: Aspiration; Drug: Bupivacaine

Control

NO INTERVENTION

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

Interventions

Aspiration PROCEDURE

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

Aspiration; Aspiration with injection

Bupivacaine DRUG

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

Also known as: Marcaine, Exparel, Sensorcaine

Aspiration with injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (13)

• 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. No abstract available.

  PMID: 19440710 BACKGROUND

• Koval KJ, Helfet DL. Tibial Plateau Fractures: Evaluation and Treatment. J Am Acad Orthop Surg. 1995 Mar;3(2):86-94. doi: 10.5435/00124635-199503000-00004.

  PMID: 10790657 BACKGROUND

• 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. doi: 10.1056/NEJM199110173251602.

  PMID: 1653901 BACKGROUND

• 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. doi: 10.2106/JBJS.E.00344.

  PMID: 16651569 BACKGROUND

• Franceschi F, Rizzello G, Cataldo R, Denaro V. Comparison of morphine and ropivacaine following knee arthroscopy. Arthroscopy. 2001 May;17(5):477-80. doi: 10.1053/jars.2001.19684.

  PMID: 11337713 BACKGROUND

• 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. doi: 10.1177/036354659502300318.

  PMID: 7661266 BACKGROUND

• 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.

  PMID: 18381308 BACKGROUND

• 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.

  PMID: 26563923 BACKGROUND

• 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.

  PMID: 19487135 BACKGROUND

• 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.

  PMID: 20932520 BACKGROUND

• 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. doi: 10.1111/j.1553-2712.2003.tb01355.x.

  PMID: 12670856 BACKGROUND

• 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. doi: 10.1213/00000539-199206000-00008.

  PMID: 1595914 BACKGROUND

• 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. doi: 10.2106/00004623-199605000-00013.

  PMID: 8642030 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The study was stopped for feasibility (low enrollment)

Results Point of Contact

• Title: William Lack, M.D.
• Organization: Loyola University Medical Center

wlack@luc.edu

708-216-1175

Study Officials

• William Lack, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study uses a single blind masking scheme
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: June 15, 2016
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: August 17, 2018
• Results First Posted: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)