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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02571283
Other study ID # 14.1276
Secondary ID
Status Withdrawn
Phase Phase 4
First received September 28, 2015
Last updated April 5, 2017
Start date October 2015
Est. completion date May 2016

Study information

Verified date April 2017
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Cocktail
Administered as a single dose injection.
Exparel
Administered 20 minutes+ before additional medications.
Marcaine
Administered 20 minutes or more after Exparel is administered.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville Arthroplasty Foundation, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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