About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Liposomal Bupivacaine
Drug10 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)
Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination
Drug20 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)
Treatment groups
Trial outcomes
Primary outcomes
Pain Score with Movement
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
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
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 outcomes
Pain Score with Rest
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 Rest
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
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
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
Sponsors and contacts
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