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

April 5, 2017 updated by: University of Louisville

A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
  • Duraclon
  • Sprix
  • Toradol
  • Acular
  • Catapres
  • Acuvail
  • EpiPen
  • Adrenaclick
  • Medihaler-Epi
  • Kapvay
  • Nexiclon
  • Twinject
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
  • Duraclon
  • Sprix
  • Toradol
  • Acular
  • Catapres
  • Acuvail
  • EpiPen
  • Adrenaclick
  • Medihaler-Epi
  • Kapvay
  • Nexiclon
  • Twinject
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
  • Bupivacaine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Pain control intervals will be assessed 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Arthroplasty Foundation, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.1276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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