Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)

Total Knee Arthroplasty Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02060591
• Other study ID #: 14PAR01
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 11, 2014
• Start date: January 2014

Study information

• Verified date: February 2014
• Source: Rothman Institute Orthopaedics
• Contact: Tiffany Morrison, MS, CCRP
• Phone: 267-339-7818
• Email: tiffany.morrison[@]rothmaninstitute.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with Marcaine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.

Exclusion Criteria:

• American Society of Anesthesiologist (ASA) score of 4 or higher

• Hepatic disease (contraindication for acetaminophen)

• Renal disease (contraindication for NSAIDs)

• Any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, Tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol

• Fibromyalgia

• Any contraindication for intrathecal opioid injection

• History of substance abuse during the last 2 years

• History of allergy to amide compounds

• Current consumption of monoaminoxidase (MAO) inhibitors and tricyclic antidepressant (TCA) medications

• Allergy to metabisulfite compounds

• Chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia)

• Body weight<50 Kg, BMI>40 Kg/m2

• History of hypotension

• Patients with any surgery related complication in the first 4-6 weeks following TKA, such as infection or mechanical failure

Study Design

N/A

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• Exparel

• Marcaine

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method		Within first 30 days post-operatively	No