Back to resultsFemoral Nerve Block Compared to Exparel in Total Knee Replacement
Primary Purpose
Osteoarthritis, Pain
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exparel
Femoral Nerve Block Bupivacaine
Toradol
Morphine Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Arthroplasty, Amide Local Anesthetic
Eligibility Criteria
Inclusion Criteria:
• Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate.
Exclusion Criteria:
- Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded.
- Patients with an ASA 4 level will be excluded.
- Patients with a Body Mass Index of less than 20, and over 40, will be excluded.
- Patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.
Sites / Locations
- New England Baptist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Femoral Nerve Block (Group 1)
Exparel (Group 2)
Arm Description
In group1 (standard group) all patients receive the standard current perioperative pain management protocol for TKR. The patient will then undergo an ultrasound guided femoral nerve block with bupivacaine 0.25% 20 cc. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint. Postoperatively patients will receive narcotic pain medication on a PRN basis.
Group 2 will receive standard perioperative pain management for TKR; will undergo placebo femoral nerve block under ultrasound guidance with normal saline (NS) 20 cc. Following femoral bone cuts they will receive local anesthetic injection mixture of 30cc 0.25% bupivicaine with epinephrine 20 cc of preservative free normal saline, 30mg of toradol and 10 mg of morphine sulfate into the periarticular tissues including periosteum, joint capsule and posterior capsule of the knee joint and collateral ligaments and subcutaneous tissues. Prior to cementing prosthesis, a second injection with mixture of 20mL 1.3% Exparel and 40mL normal saline solution will be injected into the same tissues, joint capsules and collateral ligaments.
Outcomes
Primary Outcome Measures
Pain Relief measured by VAS Questionnaire
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcomes following total knee replacement (TKR) than the current standard NEBH regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
Secondary Outcome Measures
Functional Ability measured by the KSS Questionnaire Score
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcomes following total knee replacement (TKR) than the current standard NEBH regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
Full Information
NCT ID
NCT02473198
First Posted
January 5, 2015
Last Updated
March 16, 2016
Sponsor
The New England Baptist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02473198
Brief Title
Femoral Nerve Block Compared to Exparel in Total Knee Replacement
Official Title
A Prospective Randomized Trial Comparing Femoral Nerve Black to Intraoperative Local Anesthetic Injection of Liposomal Bupivacaine (Exparel) in Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The New England Baptist Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcome following total knee replacement (TKR) than the current standard New England Baptist Hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
Detailed Description
A prospective, single blind study comparing femoral nerve blockade and intraarticular posterior capsular injection to interarticular injection of bupivicaine and liposomal bupivicaine (Exparel) alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Pain
Keywords
Total Knee Arthroplasty, Amide Local Anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Femoral Nerve Block (Group 1)
Arm Type
Active Comparator
Arm Description
In group1 (standard group) all patients receive the standard current perioperative pain management protocol for TKR.
The patient will then undergo an ultrasound guided femoral nerve block with bupivacaine 0.25% 20 cc. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint. Postoperatively patients will receive narcotic pain medication on a PRN basis.
Arm Title
Exparel (Group 2)
Arm Type
Experimental
Arm Description
Group 2 will receive standard perioperative pain management for TKR; will undergo placebo femoral nerve block under ultrasound guidance with normal saline (NS) 20 cc. Following femoral bone cuts they will receive local anesthetic injection mixture of 30cc 0.25% bupivicaine with epinephrine 20 cc of preservative free normal saline, 30mg of toradol and 10 mg of morphine sulfate into the periarticular tissues including periosteum, joint capsule and posterior capsule of the knee joint and collateral ligaments and subcutaneous tissues. Prior to cementing prosthesis, a second injection with mixture of 20mL 1.3% Exparel and 40mL normal saline solution will be injected into the same tissues, joint capsules and collateral ligaments.
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
Bupivacaine liposome injectable suspension
Intervention Description
Prior to cementing of the prosthesis (minimum 20 minutes later), injection with mixture of 40 mL normal saline solution and 20mL 1.3% Exparel.
Intervention Type
Drug
Intervention Name(s)
Femoral Nerve Block Bupivacaine
Other Intervention Name(s)
Bupivacaine
Intervention Description
The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
Intervention Type
Drug
Intervention Name(s)
Toradol
Other Intervention Name(s)
Sprix, Acuvail, Acular
Intervention Description
The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
Astramorph PF, Duramorph, Infumorph
Intervention Description
The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
Primary Outcome Measure Information:
Title
Pain Relief measured by VAS Questionnaire
Description
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcomes following total knee replacement (TKR) than the current standard NEBH regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Functional Ability measured by the KSS Questionnaire Score
Description
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcomes following total knee replacement (TKR) than the current standard NEBH regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate.
Exclusion Criteria:
Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded.
Patients with an ASA 4 level will be excluded.
Patients with a Body Mass Index of less than 20, and over 40, will be excluded.
Patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Talmo, MD
Organizational Affiliation
New England Baptist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Baptist Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Femoral Nerve Block Compared to Exparel in Total Knee Replacement
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