Back to resultsEffectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Total Knee Arthroplasty, Pain Management
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pain Cocktail with Exparel
Pain Cocktail with Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Arthroplasty, Total Knee Replacement, Exparel, Liposomal Bupivacaine, Ropivacaine, Postoperative Pain Management
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
- 18 years of age or older
- Primary diagnosis of osteoarthritis of the knee
- Opioid naïve patient (according to FDA guidelines)
Exclusion Criteria:
- Prior knee replacement
- Prior use of narcotics for chronic pain management
- Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
- Unicompartmental knee replacement
- Bilateral Total Knee Arthroplasty
- Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:
> 60 mg oral morphine/day > 25μg transdermal fentanyl/hour > 30 mg oral oxycodone/day > 8 mg oral hydromorphone/day > 25 mg oral oxymorphone/day
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pain Cocktail with Ropivacaine
Pain Cocktail with Exparel
Arm Description
patients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation. given in one single dose
patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc. given in one single dose
Outcomes
Primary Outcome Measures
Postoperative opioid consumption
oral and intravenous narcotic consumption is recorded during hospital stay
Secondary Outcome Measures
Hours to ambulate 100 feet
Length of hospital stay (hours)
Number of hours the patient stays at the hospital following operation
Visual Analog Pain Score
Knee Society Score
Full Information
NCT ID
NCT02808728
First Posted
June 14, 2016
Last Updated
June 17, 2016
Sponsor
DeClaire LaMacchia Orthopaedic Institute
1. Study Identification
Unique Protocol Identification Number
NCT02808728
Brief Title
Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty
Official Title
Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DeClaire LaMacchia Orthopaedic Institute
4. Oversight
5. Study Description
Brief Summary
Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?
The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.
Detailed Description
The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Total Knee Arthroplasty, Pain Management
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Exparel, Liposomal Bupivacaine, Ropivacaine, Postoperative Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain Cocktail with Ropivacaine
Arm Type
Active Comparator
Arm Description
patients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
given in one single dose
Arm Title
Pain Cocktail with Exparel
Arm Type
Experimental
Arm Description
patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc.
given in one single dose
Intervention Type
Drug
Intervention Name(s)
Pain Cocktail with Exparel
Other Intervention Name(s)
liposomal bupivacaine
Intervention Description
pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.
Intervention Type
Drug
Intervention Name(s)
Pain Cocktail with Ropivacaine
Intervention Description
pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
oral and intravenous narcotic consumption is recorded during hospital stay
Time Frame
immediately post-operatively through hospital stay
Secondary Outcome Measure Information:
Title
Hours to ambulate 100 feet
Time Frame
immediately post-operatively through hospital stay
Title
Length of hospital stay (hours)
Description
Number of hours the patient stays at the hospital following operation
Time Frame
immediately post-operatively through hospital stay
Title
Visual Analog Pain Score
Time Frame
day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively
Title
Knee Society Score
Time Frame
3 months, 6 months, 1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
18 years of age or older
Primary diagnosis of osteoarthritis of the knee
Opioid naïve patient (according to FDA guidelines)
Exclusion Criteria:
Prior knee replacement
Prior use of narcotics for chronic pain management
Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
Unicompartmental knee replacement
Bilateral Total Knee Arthroplasty
Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:
> 60 mg oral morphine/day > 25μg transdermal fentanyl/hour > 30 mg oral oxycodone/day > 8 mg oral hydromorphone/day > 25 mg oral oxymorphone/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olayinka Warritay, MD
Organizational Affiliation
DeClaire LaMacchia Orthopaedic Institute
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28478185
Citation
DeClaire JH, Aiello PM, Warritay OK, Freeman DC. Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study. J Arthroplasty. 2017 Sep;32(9S):S268-S271. doi: 10.1016/j.arth.2017.03.062. Epub 2017 Apr 6.
Results Reference
derived
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Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty
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