Knee Arthroplasty, Total
Conditions
Keywords
pain, knee surgery, pain management
Brief summary
The purpose of this research study is to compare two different combinations of anesthetic medications to see which works the best in providing the longest lasting pain relief for total knee arthroplasty surgery. The drugs being used are liposomal bupivacaine compared to a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Pain scores will be collected at different intervals during study participation.
Detailed description
This double-blinded prospective randomized control trial will evaluate analgesia following total knee arthroplasty for patients who receive an adductor canal block and infiltration between the popliteal artery and condyles of the knee (iPACK) block utilizing bupivacaine with the adjuvants clonidine, epinephrine, buprenorphine and dexamethasone (BPV-CEBD), as compared to patients who receive liposomal bupivacaine (LB) for both blocks. All patients will receive a spinal anesthetic with ropivacaine (17.5 mg) and fentanyl (10 mcg), and an adductor canal and iPACK block for analgesia. Patients randomized to the LB group will receive 10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of LB into both the adductor canal and iPACK blocks (total of 40 ml). The BPV-CEBD group will receive a 20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone - which will be used in both the adductor canal block and iPACK block (total of 40 ml). On post-operative day (POD) 0, rest and movement pain scores will be collected at 4 hours and 8 hours with time "zero" being the time of the final block placement. On POD 1 and 2, questionnaires will be collected for pain scores at 0700, 1200 and 1700. Participants will be called once daily on days 3 through 7 to collect remaining secondary data, including sleep score, quality of recovery, worst daily pain score, and patient satisfaction (POD 7 only).
Interventions
DRUGLiposomal Bupivacaine
10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of liposomal bupivacaine into both the adductor canal and iPACK blocks (total of 40 ml)
DRUGBupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination
20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone which will be used in both the adductor canal block and iPACK block (total of 40 ml)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18-80 years of age * Receiving primary total knee arthroplasty * Patients receiving a spinal anesthetic with ropivacaine and fentanyl * American Society of Anesthesiology (ASA) category 1 to 3
Exclusion criteria
* Revision of Total Knee Arthroplasty * Opioid use in the prior 6 months \> 40 mg oxycodone equivalents per day or long-acting opioids as determined by the Prescription Drug Monitoring Program (PDMP) * Patients planned to receive general anesthesia * Patients planned to receive a spinal other than ropivacaine * History of peripheral neuropathy * Poorly controlled diabetes (Hgb A1C \>8) * Allergies or contraindications to study medications: acetaminophen, celecoxib (including sulfa), methocarbamol, midazolam, fentanyl, bupivacaine, dexamethasone, acetaminophen, buprenorphine, NSAIDs, clonidine, epinephrine, and liposomal bupivacaine. * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score with Movement | Baseline | numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score with Rest | Hour 48 post final block placement | numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain |
| Pain Score with Movement | Hour 72 post final block placement | numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain |
| Highest Daily Pain Score | Postop Days 3, 4, 5, 6, 7 | numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain |
| Cumulative Opioid Consumption | Hour 48 post final block placement | all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 2 |
| Quality of Recovery-15 Patient Survey | Postop Days 3, 4, 5, 6, 7 | quality of life questions rated on a 0-10 scale for 0=none of the time up to 10=all of the time on a daily basis; pain/nausea/vomiting/depression questions answered in a 10=none of the time down to a 0=all of the time (scales reversed on that scale) |
| Distance Walked | 24 hours | distance (feet) walked during first physical therapy appointment |
| PROMIS Sleep Disturbance Survey | Postop Days 3, 4, 5, 6, 7 | quality of sleep rated on a scale of 0=very poor/not at all up to 5=very good/very much |
| Patient Satisfaction | Postop Day 7 | measured with a 5-point Likert scale 0=not satisfied at all up to 5=best level of satisfaction |
| Incidence of Postoperative Nausea | Up to Postop Day 7 | overall number of nausea occurrences |
| Incidence of Postoperative Vomiting | Up to Postop Day 7 | overall number of vomiting occurrences |
Countries
United States
Contacts
CONTACTAfua Gyamfi, MD
CONTACTLynnette Harris, RN
PRINCIPAL_INVESTIGATORAfua Gyamfi, MD
Atrium Health Wake Forest Baptist
Outcome results
None listed