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0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka

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ClinicalTrials.gov Identifier: NCT03303794
Recruitment Status : Not yet recruiting
First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Boleslav Kosharskyy, Montefiore Medical Center

Brief Summary:
Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Exparel Drug: 0.25% bupivacaine Phase 3

Detailed Description:

This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. Our proposed study was designed to compare two of our current standard therapies:

  1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and
  2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivicaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
Drug: 0.25% bupivacaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
Other Name: liposomal

Experimental: Bupivicaine + Exparel
0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
Drug: Exparel
1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty

Drug: 0.25% bupivacaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
Other Name: liposomal




Primary Outcome Measures :
  1. Proportion of patients fit to discharge [ Time Frame: Post-Operation Day 1 ]
    AM-PAC (activity measure for post-acute care)


Secondary Outcome Measures :
  1. Opioid consumption during the first 48 hours after TKA surgery [ Time Frame: During the first 48 hours after surgery ]
    Monitor how much opioid patient consumes

  2. pain scores during 48 hrs postoperatively [ Time Frame: 48 hours postoperatively ]
    Will use Numeric Pain Rating Scale (NPRS) to measure

  3. Discharge destination (home vs. rehab/nursing home) [ Time Frame: Average of 3 nights post-operatively ]
    Figure out if patient will be discharged to their home or a rehab/nursing home

  4. Change in WOMAC scores [ Time Frame: Preoperatively and postoperatively at 2 weeks, 3 months, and 6 months. ]
    WOMAC is a form used to assess pain, stiffness and physical function in patients with hip/knee osteoarthritis. This will be assessed preoperatively and postoperatively at two weeks, three months, and six months.

  5. Percentage of patients with additional IV pain medications needed [ Time Frame: Average of 3 nights post-operatively ]
    Standard of care medications post-operatively will be provided but if patient is not satisfied and requires additional pain medication, treating physicians will provide additional medication. Patients who need additional medications will be compared against patients who did not need additional medications.

  6. 30 day-Post-operative complications [ Time Frame: 30 days post-operative ]
    Monitor if patients encounter complications 30 days after operation.

  7. 30-day ED visit [ Time Frame: 30 days post-operative ]
    Monitor if patients visit emergency department 30 days after operation



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis
  • Ages 40- 80 years old
  • American Society of Anesthesiologists class I-III

Exclusion Criteria:

  • Refusal or absolute medical contraindication to peripheral nerve block
  • refusal or absolute medical contraindication to spinal anesthesia
  • conversion of spinal anesthesia to general anesthesia is obtained
  • inability to cooperate
  • allergy to any drug used in this study
  • daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)
  • alcohol dependence or use of any illegal drugs within the last month
  • inability to perform the mobilization test and timed up and go (TUG) test pre-operatively

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303794


Contacts
Contact: Boleslav Kosharskyy, MD 9175571746 bkoshars@montefiore.org
Contact: Singh Nair, PhD 7189205932 sinair@montefiore.org

Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Boleslav Kosharskyy, MD Montefiore Medical Center

Publications:
C. Vlessides M. New Regional Technique Controls Post-TKA Pain. Anesthesiology News. December 2012.

Responsible Party: Boleslav Kosharskyy, Director of Anesthesia for Joint Replacement Center, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03303794     History of Changes
Other Study ID Numbers: 2017-7893
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All study data will be collected and entered into the computer database. Each subject will be assigned to a random number code and the key linking the code and the subject identifier will be stored in a locked cabinet. The computer database will be password protected and will be kept on the Montefiore drive. The research manager is responsible for auditing the consistency of the data transcribed from the paper case report form to the computer. A protocol violation log will be maintained and all protocol violations will be reported to the Institutional Review Board and Data Safety Monitoring Board. The planned interim analysis (half way through the recruitment) will be mainly focused on the adverse events, rather than the efficacy of the procedure.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boleslav Kosharskyy, Montefiore Medical Center:
Total Knee arthroplasty
bupivacaine
anesthesia

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents