Arthritis
Conditions
Brief summary
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.
Detailed description
Objectives: 1. Is to assess the efficacy of pain control of Exparel vs. controls when injected into the posterior capsular space after total knee arthroplasty 2. Asses the opioid use after Exparel vs. controls 3. Asses the time to simple and complex knee movement and ambulation. 4. The safety of Exparel will be assessed by the occurrence of all postsurgical adverse events and serious adverse events through Day 30. 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.
Interventions
OTHERSaline
Saline is infiltrated into posterior compartment for control
DRUGExparel
Exparel is infiltrated into posterior compartment for pain control
Sponsors
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3 * Patients undergoing knee replacement (total knee arthroplasty) * Subjects must be physically and mentally able to participate in the study and complete all study assessments. * Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.
Exclusion criteria
* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics * Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee. * Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study. * Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s. * Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study. * History of pre-existing neurological disorders/neuropathy * Morbid Obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Pain | 72 hours post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Narcotic Use | 72 hours post-operative | Average postoperative narcotics administered in total milligrams of morphine equivalents |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side Effects of Analgesia | 72 hours post-operative | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel Inflitration Exparel infiltrated into the posterior compartment of the knee | 10 |
| Control Saline infiltrated into posterior compartment | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Exparel Inflitration | Control | Total |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 4.7 | 62.8 years STANDARD_DEVIATION 6 | 64.1 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 72 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel Group/Average Pain Scores at 4 Hours | Subjective Pain | 3.80 units on a scale | Standard Deviation 3.26 |
| Control Group/Average Pain Scores at 4 Hours | Subjective Pain | 4.00 units on a scale | Standard Deviation 2.75 |
| Exparel Group/Average Pain Scores at 8 Hours | Subjective Pain | 3.44 units on a scale | Standard Deviation 3.61 |
| Control Group/Average Pain Scores at 8 Hours | Subjective Pain | 5.30 units on a scale | Standard Deviation 3.02 |
| Exparel Group/Average Pain Scores at 12 Hours | Subjective Pain | 3.50 units on a scale | Standard Deviation 3.25 |
| Control Group/Average Pain Scores at 12 Hours | Subjective Pain | 3.90 units on a scale | Standard Deviation 2.47 |
| Exparel Group/Average Pain Scores at 24 Hours | Subjective Pain | 3.80 units on a scale | Standard Deviation 3.52 |
| Control Group/Average Pain Scores at 24 Hours | Subjective Pain | 4.20 units on a scale | Standard Deviation 2.82 |
| Exparel Group/Average Pain Scores at 48 Hours | Subjective Pain | 2.60 units on a scale | Standard Deviation 2.46 |
| Control Group/Average Pain Scores at 48 Hours | Subjective Pain | 3.50 units on a scale | Standard Deviation 2.95 |
| Exparel Group/Average Pain Scores at 72 Hours | Subjective Pain | 3.00 units on a scale | Standard Deviation 3.16 |
| Control Group/Average Pain Scores at 72 Hours | Subjective Pain | 3.70 units on a scale | Standard Deviation 3.5 |
Secondary
Post-operative Narcotic Use
Average postoperative narcotics administered in total milligrams of morphine equivalents
Time frame: 72 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel Group/Average Pain Scores at 4 Hours | Post-operative Narcotic Use | 4.31 mgs | Standard Deviation 2.4 |
| Control Group/Average Pain Scores at 4 Hours | Post-operative Narcotic Use | 5.75 mgs | Standard Deviation 3.63 |
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
Time frame: 72 hours post-operative
Population: Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exparel Group/Average Pain Scores at 4 Hours | Side Effects of Analgesia | 3 participants |
| Control Group/Average Pain Scores at 4 Hours | Side Effects of Analgesia | 2 participants |