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

NCT ID: NCT02571283

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-05-31

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.

Conditions

Total Knee Arthroplasty; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Cocktail

Intervention Type: DRUG

Administered as a single dose injection.

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

Group Type: EXPERIMENTAL

Cocktail

Intervention Type: DRUG

Administered as a single dose injection.

Exparel

Intervention Type: DRUG

Administered 20 minutes+ before additional medications.

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

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Administered 20 minutes+ before additional medications.

Marcaine

Intervention Type: DRUG

Administered 20 minutes or more after Exparel is administered.

Interventions

Cocktail

Administered as a single dose injection.

Intervention Type: DRUG

Exparel

Administered 20 minutes+ before additional medications.

Intervention Type: DRUG

Marcaine

Administered 20 minutes or more after Exparel is administered.

Intervention Type: DRUG

Other Intervention Names

Naropin; Toradol; Sprix; Acuvail; Acular; EpiPen; Adrenaclick; Medihaler-Epi; Twinject; Kapvay; Catapres; Duraclon; Nexiclon; Bupivacaine Liposome; Bupivacaine Hydrochloride; Bupivacaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arthroplasty Foundation, Inc.

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

14.1276

Identifier Type: -

Identifier Source: org_study_id