Adductor Canal Block, Arthroplasty Complications, Opioid Use, Peripheral Nerve Block
Conditions
Keywords
Total knee arthroplasty
Brief summary
The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.
Interventions
DRUGLiposomal bupivacaine
266 mg or 20 ml Liposomal Bupivacaine injectable solution
PROCEDUREDrug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and study team members involved in data collection and data processing will be blinded to the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is scheduled for elective unilateral primary TKA 2. The subject is ≥ 18 years 3. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural) 4. The patient consents for an adductor canal block 5. Willing and able to sign an informed consent.
Exclusion criteria
1. Patients unwilling or unable to consent to participate in the study. 2. Prisoners. 3. Pregnancy. 4. Reported to have mental illness or belonging to a vulnerable population. 5. Subject is \< 18 years of age. 6. Patients receiving general anesthesia for the total knee arthroplasty. 7. Subject has impaired decision-making capacity per discretion of the Investigator. 8. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate. 9. Significant pre-existing neuropathy on the operative limb. 10. Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I & II, among others). 11. Subject has sustained a significant trauma to the operative knee. 12. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months). 13. Known hypersensitivity and/or allergies to local anesthetics. 14. Previous surgery on the affected knee excluding arthroscopic or open meniscectomy. 15. Patients with impaired renal function such that they cannot receive IV Toradol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | Up to 2 weeks | Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | Up to 5 days | Number of days of hospitalization after elective admission for TKA surgery |
| Incidence of events of PONV | Up to 5 days | Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization |
| Number of participants requiring narcotic prescriptions | 2 weeks | The number of participants that require further narcotic prescriptions will be reported |
| Distance Ambulated with physical therapist | Up to 5 days | Average daily distance ambulated using the 6 minute walk test |
| Post-Operative Pain Score | Up to 5 days | Post-Operative Pain will be measured via a self-reported Visual Analog Scale (VAS) score. The VAS Pain score ranges from 1-10 with 1 being free of pain and 10 being the most pain. |
| Patient Satisfaction as per the Knee Society Score | Up to Week 6 | The Knee society score has a total score ranging from 100-0. Scores between 100 and 85 points are considered excellent results, scores between 84 and 70 points are considered good results. Scores between 69 and 60 points are considered fair, and scores less than 60 are considered poor results |
| Incidence of urinary retention from narcotic use | 2 Weeks | Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization. |
Outcome results
None listed