Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canalf and iPACK Blocks in Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal Bupivacaine, Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination.
- Who it may be relevant to
- Registry conditions: Knee Arthroplasty, Total. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty
Overview
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
- Drug Liposomal 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) - Drug Bupivacaine, 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)
Primary outcome measures
- Pain Score with Movement [Time frame: Baseline]
- Pain Score with Movement [Time frame: Hour 4 post final block placement]
- Pain Score with Movement [Time frame: Hour 8 post final block placement]
Secondary outcome measures (12)
- Pain Score with Rest [Time frame: Hour 48 post final block placement]
- Pain Score with Rest [Time frame: Hour 72 post final block placement]
- Pain Score with Movement [Time frame: Hour 72 post final block placement]
- Highest Daily Pain Score [Time frame: Postop Days 3, 4, 5, 6, 7]
- Cumulative Opioid Consumption [Time frame: Hour 48 post final block placement]
- Cumulative Opioid Consumption [Time frame: Hour 72 post final block placement]
- Quality of Recovery-15 Patient Survey [Time frame: Postop Days 3, 4, 5, 6, 7]
- Distance Walked [Time frame: 24 hours]
- PROMIS Sleep Disturbance Survey [Time frame: Postop Days 3, 4, 5, 6, 7]
- Patient Satisfaction [Time frame: Postop Day 7]
- Incidence of Postoperative Nausea [Time frame: Up to Postop Day 7]
- Incidence of Postoperative Vomiting [Time frame: Up to Postop Day 7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Atrium Health Wake Forest Baptist — Winston-Salem
Identifiers
NCT: NCT07097493 · IRB00133197