Femoral Nerve Block Compared to Exparel in Total Knee Replacement

Phase 3

• Conditions: Pain; Osteoarthritis
• Interventions: Drug: Femoral Nerve Block Bupivacaine; Drug: Exparel; Drug: Toradol; Drug: Morphine Sulfate

• Registration Number: NCT02473198
• Lead Sponsor: The New England Baptist Hospital

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-16
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 312

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral Nerve Block (Group 1)	Femoral Nerve Block Bupivacaine	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.
Exparel (Group 2)	Exparel	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.
Exparel (Group 2)	Toradol	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.
Exparel (Group 2)	Morphine Sulfate	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

New England Baptist Hospital; 🇺🇸 Boston, Massachusetts, United States