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

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 4

Conditions: Pain Management; Total Knee Arthroplasty

Treatments: Drug: Cocktail; Drug: Marcaine; Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT02571283

14.1276

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Randomized Group A [Cocktail Injection]

Experimental group

Description:

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

Treatment:

Drug: Cocktail

Randomized Group B [Cocktail Injection Plus Exparel]

Experimental group

Description:

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

Treatment:

Drug: Exparel

Drug: Cocktail

Randomized Group C [Marcaine Plus Exparel]

Experimental group

Description:

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

Treatment:

Drug: Exparel

Drug: Marcaine