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Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief.
Hypothesis: There is no difference in, the use of analgesics or the length and quality of analgesia and no decrease in the time to be able to accomplish simple to complex knee movements using Exparel infiltration when compared to controls.
Objectives:
Methods:
After institutional review board (IRB) approval, 20 subjects will be consented to participate in the study. The study includes subjects undergoing total knee arthroplasty either under general or spinal anesthesia. This study will include men and women (18 - 75 years) who have American Society of Anesthesiologist physical classification status 1 - 3 and underwent total knee arthroplasty.
Subjects will be divided into two groups, Group A (control) to receive 20ml of saline while Group B (study) to receive 20ml of liposomal bupivacaine into the posterior capsular space during total knee arthroplasty. Patients from both groups will receive a femoral nerve block with catheter placement for continuous infusion of local anesthetic. All subjects will have access to rescue analgesics after surgery. Multimodal analgesia will supplement pain as per standard care by the anesthesia team. Tylenol Orally 1g three times daily (not to exceed 4g in 24hrs), oxycontin 10mg orally, twice/day, Celebrex 200 mg orally once a day and Percocet 5/325 prn will serve as this multimodal approach. The time, day and number of requests for break through (additional) analgesia will be noted by both anesthesia team and primary care team. Pain scores will be assessed using a 0 - 10 numeric scale. Pain will be assessed for the following intervals: hospital arrival, post anesthesia care unit (PACU) arrival, 2, 4, 8, 12, 24, 48, 72, hours later and after hospital discharge 10 +/- 5 days after the block. Pain inquiries will assess both posterior and anterior aspects of the knee. Pain at rest and for simple leg movements (knee extension, straight leg raise) to fully ambulatory will be noted. These assessments will be made in conjunction with rehabilitation and physical therapy specialists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel infiltration | Experimental | Exparel infiltrated into the posterior compartment of the knee |
|
| Control | Placebo Comparator | Saline infiltrated into posterior compartment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Exparel is infiltrated into posterior compartment for pain control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Pain | Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain. | 72 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Narcotic Use | Average postoperative narcotics administered in total milligrams of morphine equivalents | 72 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects of Analgesia | Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain | 72 hours post-operative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piyush Gupta, MD | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel Inflitration | Exparel infiltrated into the posterior compartment of the knee |
| FG001 | Control | Saline infiltrated into posterior compartment of the knee |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel Inflitration | Exparel infiltrated into the posterior compartment of the knee |
| BG001 | Control | Saline infiltrated into posterior compartment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Males and females between the ages 18 and 75 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Pain | Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain. | Posted | Mean | Standard Deviation | units on a scale | 72 hours post-operative |
|
72 hours post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exparel Inflitration | Exparel infiltrated into the posterior compartment of the knee |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Piyush M Gupta | Maimonides Medical Center | 7182837189 | pgupta@maimonidesmed.org |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Saline | Other | Saline is infiltrated into posterior compartment for control |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Exparel Group/Average Pain Scores at 8 Hours |
Pain scores using the Number Rating Scale (NRS) from 0 - 10 |
| OG003 | Control Group/Average Pain Scores at 8 Hours | Pain scores using the Number Rating Scale (NRS) from 0 - 10 |
| OG004 | Exparel Group/Average Pain Scores at 12 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG005 | Control Group/Average Pain Scores at 12 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG006 | Exparel Group/Average Pain Scores at 24 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG007 | Control Group/Average Pain Scores at 24 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG008 | Exparel Group/Average Pain Scores at 48 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG009 | Control Group/Average Pain Scores at 48 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG010 | Exparel Group/Average Pain Scores at 72 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
| OG011 | Control Group/Average Pain Scores at 72 Hours | Pain scores using the Numeric Rating Scale (NRS) 0 - 10 |
|
|
| Secondary | Post-operative Narcotic Use | Average postoperative narcotics administered in total milligrams of morphine equivalents | Posted | Mean | Standard Deviation | mgs | 72 hours post-operative |
|
|
|
| Other Pre-specified | Side Effects of Analgesia | Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain | Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain | Posted | Number | participants | 72 hours post-operative |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | Saline infiltrated into posterior compartment | 0 | 10 | 0 | 10 |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |