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

Phase 4

Withdrawn

• Conditions: Total Knee Arthroplasty; Pain Management
• Interventions: Drug: Cocktail; Drug: Exparel; Drug: Marcaine

• Registration Number: NCT02571283
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-09-28
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized Group B [Cocktail Injection Plus Exparel]	Cocktail	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
Randomized Group A [Cocktail Injection]	Cocktail	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
Randomized Group B [Cocktail Injection Plus Exparel]	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
Randomized Group C [Marcaine Plus Exparel]	Marcaine	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
Randomized Group C [Marcaine Plus Exparel]	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

Primary Outcome Measures

Name	Time	Method
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.