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Clinical Trials/NCT02607579
NCT02607579
Unknown
N/A

A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty

Monmouth Medical Center1 site in 1 country200 target enrollmentJanuary 2015

Overview

Phase
N/A
Intervention
Ropivacaine
Conditions
Knee Osteoarthritis
Sponsor
Monmouth Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Pain relief
Last Updated
9 years ago

Overview

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.

Detailed Description

Total knee arthroplasty (TKA) is associated with intense early postoperative pain. Effective pain management following total knee arthroplasty is imperative to facilitate early ambulation, mobilization and rehabilitation. The postoperative pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. To manage postoperative pain effectively, multimodal analgesia including acetaminophen, Toradol, Solu-Medrol, opioids and local anesthetics are used. Periarticular infiltration performed intra-operatively combined with ultrasound guided adductor-canal peripheral nerve blocks are effective in reducing pain following a TKA without causing quadriceps motor block which can impede mobilization. There are no published trials that the investigators could find to date, comparing adductor canal block with a single dose Exparel and adductor canal block with standard ropivacaine. A liposome is a manufactured spherical lipid vesicle that can be used to slowly release a drug thereby extending its duration of action. Exparel is such a compound that slowly releases bupivacaine. Local anesthetics block the conduction of all excitable tissue in a dose related fashion. The first tissues that are affected are nerves, which make these drugs of choice in neural block. Their local adverse effects include neurovascular manifestations are prolonged numbness, tingling, feeling of "pins and needles" or strange sensations. These effects are reversed with time. There are no additional potential risks or adverse effects due to the procedures or drugs being administered. The procedure is well established and the local anesthetics have a history of long term use in humans.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
July 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Plyler

Orthopaedic Surgeon/ Researcher

Monmouth Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.

Exclusion Criteria

  • Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery

Arms & Interventions

Ropivacaine

This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.

Intervention: Ropivacaine

Exparel

This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.

Intervention: Exparel

Outcomes

Primary Outcomes

Pain relief

Time Frame: Hospital course (approximately 2-3 days)

The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).

Secondary Outcomes

  • 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 Sites (1)

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