Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02060591
Other study ID # 14PAR01
Secondary ID
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. completion date
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


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
See also
  Status Clinical Trial Phase
Completed NCT03542981 - Interferential Current Therapy After Total Knee Arthroplasty N/A
Recruiting NCT04458480 - Effect of Fast Inpatient Rehabilitation After TKA
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Recruiting NCT05391828 - Persona MC vs PS RCT With ROSA N/A
Active, not recruiting NCT04850300 - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses Phase 3
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Enrolling by invitation NCT05130216 - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Withdrawn NCT02495805 - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty N/A
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Withdrawn NCT01511211 - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic Phase 4
Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
Not yet recruiting NCT00958945 - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements N/A
Completed NCT00985920 - Topical Tranexamic Acid for Total Knee Arthroplasty Phase 4
Completed NCT00761956 - A Study to Compare the NexGen CR and CR-Flex Knee Implants N/A
Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
Recruiting NCT05962970 - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty N/A
Completed NCT03317834 - Navio With Total Knee Arthroplasty
Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A