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Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

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ClinicalTrials.gov Identifier: NCT02571283
Recruitment Status : Withdrawn (PI decided to focus on more current topics of interest.)
First Posted : October 8, 2015
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Arthroplasty Foundation, Inc.
Information provided by (Responsible Party):
University of Louisville

Brief Summary:

A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either:

  1. a local cocktail.
  2. a local cocktail plus Exparel.
  3. marcaine plus Exparel prior to wound closure following knee arthroplasty.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Pain Management Drug: Cocktail Drug: Exparel Drug: Marcaine Phase 4

Detailed Description:

As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control.

Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either:

  1. a local cocktail.
  2. a local cocktail plus Exparel.
  3. marcaine plus Exparel prior to wound closure following knee arthroplasty.

METHODOLOGY

Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
Study Start Date : October 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Randomized Group A [Cocktail Injection]

COCKTAIL INJECTION:

Cocktail Injection Consists of:

Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1 mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose

Drug: Cocktail
Administered as a single dose injection.
Other Names:
  • Naropin
  • Toradol
  • Sprix
  • Acuvail
  • Acular
  • EpiPen
  • Adrenaclick
  • Medihaler-Epi
  • Twinject
  • Kapvay
  • Catapres
  • Duraclon
  • Nexiclon

Experimental: Randomized Group B [Cocktail Injection Plus Exparel]

COCKTAIL INJECTION PLUS EXPAREL:

Cocktail Injection Consists of:

Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose

Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose

Drug: Cocktail
Administered as a single dose injection.
Other Names:
  • Naropin
  • Toradol
  • Sprix
  • Acuvail
  • Acular
  • EpiPen
  • Adrenaclick
  • Medihaler-Epi
  • Twinject
  • Kapvay
  • Catapres
  • Duraclon
  • Nexiclon

Drug: Exparel
Administered 20 minutes+ before additional medications.
Other Name: Bupivacaine Liposome

Experimental: Randomized Group C [Marcaine Plus Exparel]

MARCAINE PLUS EXPAREL:

Bupivacaine Hydrochloride (Brand Name: Marcaine, Sensorcaine) Dosage Form: Injection Dosage: 3 ml vial, 0.5% solution Frequency: Single dose

Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose

Drug: Exparel
Administered 20 minutes+ before additional medications.
Other Name: Bupivacaine Liposome

Drug: Marcaine
Administered 20 minutes or more after Exparel is administered.
Other Names:
  • Bupivacaine Hydrochloride
  • Bupivacaine




Primary Outcome Measures :
  1. The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively. [ Time Frame: Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained
  • The subject underwent a primary total knee replacement under adductor canal block with general anesthesia

Exclusion Criteria:

  • The subject is a minor
  • The subject is on chronic narcotics
  • The subject has an indwelling pain pump
  • The subject is having a knee revision surgery
  • The subject is having a partial knee replacement
  • The subject has a history of sepsis in a previously replaced joint
  • The subject has back pain
  • The subject has radicular pain
  • The subject suffers from depression
  • The subject has fibromyalgia
  • The subject is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims

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Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT02571283    
Other Study ID Numbers: 14.1276
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Keywords provided by University of Louisville:
Total Knee Arthroplasty
Total Knee Replacement
Exparel
Cocktail Injection
Pain Management
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketorolac Tromethamine
Ketorolac
Clonidine
Epinephrine
Racepinephrine
Bupivacaine
Ropivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents