Knee Arthroplasty, TotalPhase 4NCT07097493
Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canalf and iPACK Blocks in Total Knee Arthroplasty
A Phase 4 study testing Liposomal Bupivacaine and Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination in people with Knee Arthroplasty, Total, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Liposomal Bupivacaine and Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Afua Gyamfi, MD, 336-716-4498, agyuamfi@wakehealth.edu
James Turner, MD, 336-716-4498, jturner@wakehealth.edu
About this study
Official title: Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty
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.
Read the 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).
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Liposomal Bupivacaine, Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination
- Keywords
- pain, knee surgery, pain management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
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)
Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) CombinationDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | randomized to liposomal bupivacaine in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block Receives: Drug: Liposomal Bupivacaine |
| Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) | Active comparator | randomized to bupivacaine mixed with clonidine, epinephrine, buprenorphine and dexamethasone in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block Receives: Drug: Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Hour 4 post final block placement
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
Measured: Hour 8 post final block placement
Secondary outcomes (12)
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
Measured: Hour 48 post final block placement
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
Measured: Hour 72 post final block placement
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
Measured: Hour 72 post final block placement
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
Measured: Postop Days 3, 4, 5, 6, 7
Cumulative Opioid Consumption
all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 2
Measured: Hour 48 post final block placement
Cumulative Opioid Consumption
all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 3
Measured: Hour 72 post final block placement
Quality of Recovery-15 Patient Survey
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)
Measured: Postop Days 3, 4, 5, 6, 7
Distance Walked
distance (feet) walked during first physical therapy appointment
Measured: 24 hours
PROMIS Sleep Disturbance Survey
quality of sleep rated on a scale of 0=very poor/not at all up to 5=very good/very much
Measured: Postop Days 3, 4, 5, 6, 7
Patient Satisfaction
measured with a 5-point Likert scale 0=not satisfied at all up to 5=best level of satisfaction
Measured: Postop Day 7
Incidence of Postoperative Nausea
overall number of nausea occurrences
Measured: Up to Postop Day 7
Incidence of Postoperative Vomiting
overall number of vomiting occurrences
Measured: Up to Postop Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startFeb 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afua Gyamfi, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097493
- Sponsor's protocol ID
- IRB00133197
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07097493
- Acronym / sponsor ID
- IRB00133197
- Conditions
- Knee Arthroplasty, Total
- Keywords
- pain, knee surgery, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Drug: Liposomal Bupivacainerandomized to liposomal bupivacaine in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block |
| Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) | Active comparator | Drug: Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combinationrandomized to bupivacaine mixed with clonidine, epinephrine, buprenorphine and dexamethasone in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal Bupivacaine10 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 | Liposomal Bupivacaine |
| Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination20 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) | Drug | Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) |
Primary outcome
Pain Score with Movement
Time frame: 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
Pain Score with Movement
Time frame: Hour 4 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
Time frame: Hour 8 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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afua Gyamfi, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivacaine and Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination in people with Knee Arthroplasty, Total, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afua Gyamfi, MD (336-716-4498, agyamfi@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score with Movement (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.