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

Sponsor

University of Louisville (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02571283

Collaborator

Arthroplasty Foundation, Inc. (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

a local cocktail.
a local cocktail plus Exparel.
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:

a local cocktail.
a local cocktail plus Exparel.
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.

Study Design

Study Type:

Interventional

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 :

Oct 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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 Names:

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 Names:

Bupivacaine Liposome

Drug: Marcaine

Administered 20 minutes or more after Exparel is administered.

Other Names:

Bupivacaine Hydrochloride

Bupivacaine

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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