Femoral Nerve Block Compared to Exparel in Total Knee Replacement

Sponsor
The New England Baptist Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02473198
Collaborator
(none)
312
1
2
37
8.4

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
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

Study Type:
Interventional
Anticipated Enrollment :
312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Trial Comparing Femoral Nerve Black to Intraoperative Local Anesthetic Injection of Liposomal Bupivacaine (Exparel) in Total Knee Replacement
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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:
  • Bupivacaine
  • 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:
  • Bupivacaine liposome injectable suspension
  • 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:
  • Sprix
  • Acuvail
  • Acular
  • 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:
  • Astramorph PF
  • Duramorph
  • Infumorph
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Ages Eligible for Study:
    18 Years to 73 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Carl Talmo, Principal Investigator, The New England Baptist Hospital
    ClinicalTrials.gov Identifier:
    NCT02473198
    Other Study ID Numbers:
    • 463360
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Mar 17, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Carl Talmo, Principal Investigator, The New England Baptist Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2016