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

NCT02571283 | Withdrawn Phase 4 DMC

• 1 other identifier: 14.1276
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Conditions

Total Knee Arthroplasty; Pain Management

Keywords

Total Knee Arthroplasty; Total Knee Replacement; Exparel; Cocktail Injection; Pain Management

Outcome Measures

Primary Outcomes (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.

  Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.

Study Arms (3)

Randomized Group A [Cocktail Injection]

EXPERIMENTAL

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

Randomized Group B [Cocktail Injection Plus Exparel]

EXPERIMENTAL

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; Drug: Exparel

Randomized Group C [Marcaine Plus Exparel]

EXPERIMENTAL

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; Drug: Marcaine

Interventions

Cocktail DRUG

Administered as a single dose injection.

Also known as: Naropin, Toradol, Sprix, Acuvail, Acular, EpiPen, Adrenaclick, Medihaler-Epi, Twinject, Kapvay, Catapres, Duraclon, Nexiclon

Randomized Group A [Cocktail Injection]; Randomized Group B [Cocktail Injection Plus Exparel]

Exparel DRUG

Administered 20 minutes+ before additional medications.

Also known as: Bupivacaine Liposome

Randomized Group B [Cocktail Injection Plus Exparel]; Randomized Group C [Marcaine Plus Exparel]

Marcaine DRUG

Administered 20 minutes or more after Exparel is administered.

Also known as: Bupivacaine Hydrochloride, Bupivacaine

Randomized Group C [Marcaine Plus Exparel]

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Arthroplasty Foundation, Inc.: collaborator

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Ketorolac Tromethamine; Ketorolac; Epinephrine; Clonidine; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 6, 2017

Record last verified: 2017-04