Anesthesia
Conditions
Keywords
Total Knee arthroplasty, bupivacaine, anesthesia
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.
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. The 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.
Interventions
DRUGExparel
1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
0.25% bupivacaine in patients undergoing total knee arthroplasty
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AM-PAC Score to Measure Patients Fitness for Discharge | Post-Operation Day 1 | AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption During the First 48 Hours After TKA Surgery | During the first 48 hours after surgery | Monitor how much opioid patient consumes |
| Pain Scores During 48 Hrs Postoperatively | 48 hours postoperatively | Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivicaine 0.25% bupivacaine in patients undergoing total knee arthroplasty
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty | 13 |
| Bupivicaine + Exparel 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Bupivicaine + Exparel | Total | Bupivicaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 19 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 0 Participants |
| Age, Continuous | 67 years | 70 years | 71 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
AM-PAC Score to Measure Patients Fitness for Discharge
AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.
Time frame: Post-Operation Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivicaine | AM-PAC Score to Measure Patients Fitness for Discharge | 23 score on scale |
| Bupivicaine + Exparel | AM-PAC Score to Measure Patients Fitness for Discharge | 23 score on scale |
Secondary
Opioid Consumption During the First 48 Hours After TKA Surgery
Monitor how much opioid patient consumes
Time frame: During the first 48 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivicaine | Opioid Consumption During the First 48 Hours After TKA Surgery | 90 milligram |
| Bupivicaine + Exparel | Opioid Consumption During the First 48 Hours After TKA Surgery | 76 milligram |
Secondary
Pain Scores During 48 Hrs Postoperatively
Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.
Time frame: 48 hours postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivicaine | Pain Scores During 48 Hrs Postoperatively | 4 score on scale |
| Bupivicaine + Exparel | Pain Scores During 48 Hrs Postoperatively | 4 score on scale |