Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in patients undergoing primary unilateral total knee arthroplasty.
EXPAREL is approved by the Food and Drug Administration (FDA) for use in adults to produce postsurgical regional analgesia via an adductor canal block. The purpose of this study is to evaluate the clinical utility of a surgeon administered EXPAREL adductor canal block intraoperatively in patients undergoing primary unilateral total knee arthroplasty (TKA).
Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively. Visual Analog Scale, patient reported outcomes, and patient's satisfaction with pain management will be recorded. Adverse events will be monitored.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Patients will receive an EXPAREL IPSA block intraoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | 20 milliliter (mL) EXPAREL with 20mL bupivacaine hydrochloride (HCL) 0.5% will be expanded. An 18-gauge bevel needle will be introduced through the capsular pocket at 1 to 2cm proximal to the adductor tubercle at the proximal border of the posteromedial femoral condyle. The needle will be angled proximally and posteriorly, and then advanced to contact the posteromedial capsule. A 20mL bolus of the study drug admixture will be administered. The remaining 20mL of the study drug admixture will be administered to the anterior and lateral knee structures with approximately 1 to 1.5mL administered with each stick to the intended area. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment - 24hr recall | On a 0-10 scale, record worst pain in the last 24 hours and average pain in the last 24 hours, with 0 being no pain at all and 10 being the worst pain possible. | Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42 |
| Pain Assessment - current pain | On a 0-10 scale, record current pain level, with 0 being no pain at all and 10 being the worst pain possible. | Study Enrollment, On Admission to Surgery, on Post Anesthesia Care Unit (PACU) Admission, every 15 minutes from PACU admission to discharge home, 12 hours after surgery, Post-operative Day (POD) 1, POD 2, POD 3, POD 14, POD 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | Patient reported outcome on overall knee health where 0 represents total knee disability and 100 represents perfect knee health. | Enrollment, Post-operative Day 14, Post-operative Day 42 |
| Forgotten Joint Score |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Oral temperature will be taken in Fahrenheit | Before study medication administration, upon arrival in PACU, 12 hours after surgery |
| Resting heart rate | beats per minute |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Mihalko, MD, PhD | Campbell Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbell Clinic | Germantown | Tennessee | 38138 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Patient reported outcome on patient's awareness of their artificial joint. The higher the score, the less aware the patient is about their joint during activities of daily living. |
| Post-operative Day 14, Post-operative Day 42 |
| Breakthrough Pain Assessment | On a 0-10 scale, record current pain score before administration of breakthrough pain medication in PACU where 0 represents no pain at all and 10 represents worst pain possible. | In PACU before administration of breakthrough pain medication |
| Patient Satisfaction with Pain Management | On a 0-10 scale, record patient's satisfaction with pain management where 0 represents not satisfied at all and 10 represents very satisfied. | 12 hours after surgery, Post-operative Day 14, Post-operative Day 42 |
| Before study medication administration, upon arrival in PACU, 12 hours after surgery |
| Blood pressure | Systolic and diastolic blood pressure will be measured in millimeter of mercury | Before study medication administration, upon arrival in PACU, 12 hours after surgery |
| Respiratory rate | Breath per minute | Before study medication administration, upon arrival in PACU, 12 hours after surgery |
| Oxygen saturation | Measured by pulse oximetry in percent | Before study medication administration, upon arrival in PACU, 12 hours after surgery |
| Concomitant medication use | Any medication use, including opioids and analgesics | From signing informed consent form through 72 hours post-surgery. |
| Adverse Event | Any adverse event that patient experiences | From day of surgery to postoperative day 42 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |