Femoral Nerve Block Compared to Exparel in Total Knee Replacement

The New England Baptist Hospital

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis; Pain

Treatments: Drug: Femoral Nerve Block Bupivacaine; Drug: Toradol; Drug: Exparel; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT02473198

463360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 312 estimated patients

Sex: All

Ages: 18 to 73 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

Femoral Nerve Block (Group 1)

Active Comparator group

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.

Treatment:

Drug: Femoral Nerve Block Bupivacaine

Exparel (Group 2)

Experimental group

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.

Treatment:

Drug: Morphine Sulfate

Drug: Toradol

Drug: Exparel