Femoral Nerve Block Compared to Exparel in Total Knee Replacement
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Femoral Nerve Block (Group 1) 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. |
Drug: Femoral Nerve Block Bupivacaine
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.
Other Names:
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Experimental: Exparel (Group 2) 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. |
Drug: Exparel
Prior to cementing of the prosthesis (minimum 20 minutes later), injection with mixture of 40 mL normal saline solution and 20mL 1.3% Exparel.
Other Names:
Drug: Toradol
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.
Other Names:
Drug: Morphine Sulfate
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Pain Relief measured by VAS Questionnaire [One Year]
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 [One Year]
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.
Eligibility Criteria
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:
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Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded.
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Patients with an ASA 4 level will be excluded.
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Patients with a Body Mass Index of less than 20, and over 40, will be excluded.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | New England Baptist Hospital | Boston | Massachusetts | United States | 02120 |
Sponsors and Collaborators
- The New England Baptist Hospital
Investigators
- Principal Investigator: Carl Talmo, MD, New England Baptist Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 463360