NCT02473198

Femoral Nerve Block Compared to Exparel in Total Knee Replacement

A Prospective Randomized Trial Comparing Femoral Nerve Black to Intraoperative Local Anesthetic Injection of Liposomal Bupivacaine (Exparel) in Total Knee Replacement

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: The New England Baptist Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 73 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Pain

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-06-16
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States