Femoral Nerve Block Compared to Exparel in Total Knee Replacement

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02473198
• Other study ID #: 463360
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 5, 2015
• Last updated: March 16, 2016
• Start date: January 2014
• Est. completion date: February 2017

Study information

• Verified date: March 2016
• Source: The New England Baptist Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 73 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	New England Baptist Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The New England Baptist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One Year	No
Secondary	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.	One Year	No