Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty
A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this prospective study is to examine the effect of two local anesthetics used in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay. The two agents are bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jan 2015
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 27, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 27, 2017
April 1, 2017
1.4 years
July 27, 2015
April 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain relief
The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).
Hospital course (approximately 2-3 days)
Secondary Outcomes (4)
Length of stay
Hospital course (approximately 2-3 days)
Post-Operative Range of Motion
Hospital course (approximately 2-3 days)
Post-Operative Distance Walked
Hospital course (approximately 2-3 days)
Amount of Narcotics required
Hospital course (approximately 2-3 days)
Study Arms (2)
Ropivacaine
ACTIVE COMPARATORThis group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.
Exparel
EXPERIMENTALThis group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.
You may not qualify if:
- Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic Surgeon/ Researcher
Study Record Dates
First Submitted
July 27, 2015
First Posted
November 18, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2017
Last Updated
April 27, 2017
Record last verified: 2017-04