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Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exparel
Ropivacaine
Sponsored by
Monmouth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.

Exclusion Criteria:

  • Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery

Sites / Locations

  • Monmouth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ropivacaine

Exparel

Arm Description

This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.

This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.

Outcomes

Primary Outcome Measures

Pain relief
The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).

Secondary Outcome Measures

Length of stay
The investigators will compare the length of stay between the two groups.
Post-Operative Range of Motion
The investigators will compare the range of motion between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.
Post-Operative Distance Walked
The investigators will compare the distance walked between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.
Amount of Narcotics required
The investigators will monitor the amount of medication taken by participants during the hospital stay.

Full Information

First Posted
July 27, 2015
Last Updated
April 26, 2017
Sponsor
Monmouth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02607579
Brief Title
Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty
Official Title
A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monmouth Medical Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this prospective study is to examine the effect of two local anesthetics used in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay. The two agents are bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay.
Detailed Description
Total knee arthroplasty (TKA) is associated with intense early postoperative pain. Effective pain management following total knee arthroplasty is imperative to facilitate early ambulation, mobilization and rehabilitation. The postoperative pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. To manage postoperative pain effectively, multimodal analgesia including acetaminophen, Toradol, Solu-Medrol, opioids and local anesthetics are used. Periarticular infiltration performed intra-operatively combined with ultrasound guided adductor-canal peripheral nerve blocks are effective in reducing pain following a TKA without causing quadriceps motor block which can impede mobilization. There are no published trials that the investigators could find to date, comparing adductor canal block with a single dose Exparel and adductor canal block with standard ropivacaine. A liposome is a manufactured spherical lipid vesicle that can be used to slowly release a drug thereby extending its duration of action. Exparel is such a compound that slowly releases bupivacaine. Local anesthetics block the conduction of all excitable tissue in a dose related fashion. The first tissues that are affected are nerves, which make these drugs of choice in neural block. Their local adverse effects include neurovascular manifestations are prolonged numbness, tingling, feeling of "pins and needles" or strange sensations. These effects are reversed with time. There are no additional potential risks or adverse effects due to the procedures or drugs being administered. The procedure is well established and the local anesthetics have a history of long term use in humans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.
Arm Title
Exparel
Arm Type
Experimental
Arm Description
This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
Pain relief
Description
The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).
Time Frame
Hospital course (approximately 2-3 days)
Secondary Outcome Measure Information:
Title
Length of stay
Description
The investigators will compare the length of stay between the two groups.
Time Frame
Hospital course (approximately 2-3 days)
Title
Post-Operative Range of Motion
Description
The investigators will compare the range of motion between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.
Time Frame
Hospital course (approximately 2-3 days)
Title
Post-Operative Distance Walked
Description
The investigators will compare the distance walked between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.
Time Frame
Hospital course (approximately 2-3 days)
Title
Amount of Narcotics required
Description
The investigators will monitor the amount of medication taken by participants during the hospital stay.
Time Frame
Hospital course (approximately 2-3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3. Exclusion Criteria: Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery
Facility Information:
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States

12. IPD Sharing Statement

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Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

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