Total Knee ReplacementPhase 2Yale SEVENNCT05279092
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
A Phase 2 study testing Bupivacaine-Liposomal Bupivacaine and Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate in people with Total Knee Replacement and Knee Arthroplasty, run by Yale University at 2 sites in United States.
Trial summary
The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Knee Arthroplasty
- What is being tested?
- Bupivacaine-Liposomal Bupivacaine and Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2022to Mar 2028
- Phase
- Phase 2
- 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
- American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Who cannot join
- Refusal of consent
- Pregnancy
- Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically
- Coagulopathy
- Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB
- Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)
Show all 14Show fewer
- Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >200mg/dl, or HbA1C > 8.0%
- Peripheral Nerve Block site or systemic infection
- Immune compromise (e.g., HIV, chronic glucocorticoid use)
- Severe pre-existing neuropathy
- TKA for indications other than osteoarthritis such as post-traumatic injury or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or bilateral TKA
- Severe hepatic or renal dysfunction (GFR <50 ml/min)
- Actual body weight <60 kg
- Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Hospital Saint Raphael Campus
New Haven, Connecticut, 06520
Jinlei Li, MD PhD, 475-434-4038, jinlei.li@yale.edu
- Recruiting
Yale New Haven Hospital York Street Campus
New Haven, Connecticut, 06520
Jinlei Li, MD PhD, 475-434-4038, jinlei.li@yale.edu
About this study
Official title: Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study
The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.
This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.
Read the detailed description
This phase 2, double blinded and randomized clinical trial will investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA).
The primary objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing total knee arthroplasty (TKA). The secondary objective of this study is to test the effects of perineural use of B-DEX-MPA vs B-LB on the quality of postoperative recovery as well as surgical outcome and neuropathic pain among patients undergoing unilateral TKA.
This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.
This will be a single center study at Yale New Haven Hospital (YNHH) performed at two clinical sites: York St. Campus (York Street, New Haven) and St. Raphael Campus (Chapel Street, New Haven). 250 primary, elective and unilateral TKA patients will be enrolled, and equally randomized (1:1 ratio) to receive peripheral nerve blockade with B- LB or B-DEX-MPA.
- Conditions
- Total Knee Replacement, Knee Arthroplasty
- Being tested
- Bupivacaine-Liposomal Bupivacaine, Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-Liposomal BupivacaineDrug
Adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an iPACK block
Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone AcetateDrug
Adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine-Liposomal Bupivacaine (B-LB) | Active comparator | Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block. Receives: Drug: Bupivacaine-Liposomal Bupivacaine |
| Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA) | Experimental | Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block. Receives: Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Knee Pain Score
Average postoperative knee pain scores for the first two postoperative days using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).
Measured: Day 1 and Day 2
Postoperative opioid consumption
In-hospital postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored up to 48-hour between anesthesia end time and discharge time
Measured: From anesthesia end time to discharge time, up to 48 hours
Secondary outcomes (14)
Average Postoperative Knee Pain Score
Average postoperative knee pain scores for postoperative day 7 using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).
Measured: Day 7
Worst and best pain score
Worst and best postoperative knee pain scores for days 1, 2 and 7 using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).
Measured: Day 1, Day 2 and Day 7
Change in functional pain using Brief Pain Inventory (BPI)
Compare functional pain using the BPI at baseline, 6 weeks and 3 months. The BPI scale defines pain as follows: Score: 1 - 4 = Mild Pain, Score: 5 - 6 = Moderate Pain, Score: 7 - 10 = Severe Pain.
Measured: baseline, 6 weeks and 3 months
Change in neuropathic pain using PainDetect
Compare neuropathic pain at baseline, 6 weeks and 3 months using PainDetect: a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain.
Measured: baseline, 6 weeks and 3 months
Persistent opioid use using Yale Postoperative Recovery Scale
Persistent opioid use will be compared using the Yale Postoperative Recovery Scale on postoperative day 7, 6 weeks and 3 months. It is comprised of 3 free-text questions: Is patient still taking opioid medications, Yes or No; The number of pills left in pill box;and Has the patient needed a prescription refill, Yes or No.
Measured: Day 7, 6 weeks and 3 months
Persistent opioid use using NarX
Persistent opioid use will be compared using the NarX score at 6 weeks and 3 months, scores range from 000-999; higher scores indicate more opioid usage
Measured: 6 weeks and 3 months
Change in Quality of Recovery 40 questionnaire
40 questions assessing quality of recovery graded on a five-point Likert scale, total score range from 40 (extremely poor recovery) to 200 (excellent recovery)
Measured: Day 1, 2 and 7
Prosthetic joint range of motion
Compare prosthetic joint range of motion using the patient's electronic medical record as reported by the physical therapist at baseline, day 0, day 1, and day 2
Measured: baseline, day 0, day 1 and day 2
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
The PROMIS Global-10 is a 10-item patient-reported questionnaire that measures changes in general health in which the response options are presented as 5-point scale, 5 (without any difficulty) to 1 (Unable to do). Higher scores indicate a healthier patient.
Measured: 6 weeks and 3 months
Change in knee functional status using Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Compare knee functional status using KOOS JR at 6 weeks and 3 months after surgery, Scores range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health.
Measured: 6 weeks and 3 months
Length of stay
The patient's post surgical length of stay in the hospital will be compared between treatment groups.
Measured: from the start of the surgery to discharge from hospital, up to 48 hours
Change in glucose
Compare the change in postoperative serum glucose from baseline only for participants that have an overnight hospital stay
Measured: baseline, day 0, day 1 and day 2
Change in white blood cell count (WBC)
Compare the change in postoperative WBC from baseline only for participants that have an overnight hospital stay
Measured: baseline, day 0, day 1 and day 2
Absolute value of Interleukin 1 beta (IL-1b)
Absolute value IL-1b at postoperative day 1 only for participants that have an overnight hospital stay
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start8 Sep 2022
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anesthesiology Faculty Development Fund
- Responsible party
- Sponsor
- Investigators
- Jinlei Li, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279092
- Sponsor's protocol ID
- 2000031881
- Other IDs
- 000
- Acronym
- Yale SEVEN
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study
- ClinicalTrials.gov ID
- NCT05279092
- Acronym / sponsor ID
- Yale SEVEN / 2000031881
- Conditions
- Total Knee Replacement, Knee Arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Department of Anesthesiology Faculty Development Fund
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Mar 2022 (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 objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.
This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.
Detailed description
This phase 2, double blinded and randomized clinical trial will investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA).
The primary objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing total knee arthroplasty (TKA). The secondary objective of this study is to test the effects of perineural use of B-DEX-MPA vs B-LB on the quality of postoperative recovery as well as surgical outcome and neuropathic pain among patients undergoing unilateral TKA.
This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.
This will be a single center study at Yale New Haven Hospital (YNHH) performed at two clinical sites: York St. Campus (York Street, New Haven) and St. Raphael Campus (Chapel Street, New Haven). 250 primary, elective and unilateral TKA patients will be enrolled, and equally randomized (1:1 ratio) to receive peripheral nerve blockade with B- LB or B-DEX-MPA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine-Liposomal Bupivacaine (B-LB) | Active comparator | Drug: Bupivacaine-Liposomal BupivacaineNerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block. |
| Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA) | Experimental | Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone AcetateNerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Key exclusion criteria (14 listed)
- Refusal of consent
- Pregnancy
- Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically
- Coagulopathy
- Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB
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 |
|---|---|---|
| Bupivacaine-Liposomal BupivacaineAdductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an iPACK block | Drug | Bupivacaine-Liposomal Bupivacaine (B-LB) |
| Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone AcetateAdductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block. | Drug | Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA) |
Primary outcome
Postoperative Knee Pain Score
Time frame: Day 1 and Day 2
Average postoperative knee pain scores for the first two postoperative days using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).
Postoperative opioid consumption
Time frame: From anesthesia end time to discharge time, up to 48 hours
In-hospital postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored up to 48-hour between anesthesia end time and discharge time
14 secondary outcomes
Average Postoperative Knee Pain Score
Time frame: Day 7
Worst and best pain score
Time frame: Day 1, Day 2 and Day 7
Change in functional pain using Brief Pain Inventory (BPI)
Time frame: baseline, 6 weeks and 3 months
Change in neuropathic pain using PainDetect
Time frame: baseline, 6 weeks and 3 months
Persistent opioid use using Yale Postoperative Recovery Scale
Time frame: Day 7, 6 weeks and 3 months
Persistent opioid use using NarX
Time frame: 6 weeks and 3 months
Change in Quality of Recovery 40 questionnaire
Time frame: Day 1, 2 and 7
Prosthetic joint range of motion
Time frame: baseline, day 0, day 1 and day 2
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
Time frame: 6 weeks and 3 months
Change in knee functional status using Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Time frame: 6 weeks and 3 months
Length of stay
Time frame: from the start of the surgery to discharge from hospital, up to 48 hours
Change in glucose
Time frame: baseline, day 0, day 1 and day 2
Change in white blood cell count (WBC)
Time frame: baseline, day 0, day 1 and day 2
Absolute value of Interleukin 1 beta (IL-1b)
Time frame: day 1
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 23 Jul 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.
Jinlei Li, MD PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine-Liposomal Bupivacaine and Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate in people with Total Knee Replacement and Knee Arthroplasty, run by Yale University at 2 sites 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 1 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jinlei Li, MD PhD (475-434-4038, jinlei.li@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Knee Pain Score (time frame: Day 1 and Day 2). The study lists 2 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 23 Jul 2026.