Recruiting

Adjunctive Pain Medications

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT02060591

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exparel

Marcaine

Study Details

Brief 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.

Conditions

Total Knee Arthroplasty

Study ID

NCT02060591

Start date

Jan, 2014

Status verified date

Feb, 2014

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Interventions and Outcome Measures

Arms

active comparator: Exparel

active comparator: Marcaine

Interventions

Exparel

Marcaine

Primary outcome measure

  • 2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method [ Time Frame: Within first 30 days post-operatively ]

Central Contacts and Locations

Central contacts

Tiffany Morrison, MS, CCRP

267-339-7818tiffany.morrison@rothmaninstitute.com

Locations

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Tiffany Morrison, MS, CCRP

267-339-7818tiffany.morrison@rothmaninstitute.com

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Feb 12, 2014

Last verified

Feb, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2014-02-12.