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NCT Number: NCT05279092

Yale Steroid Enhanced Versus Exparel Nerveblock TKA 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.

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Key information

Conditions

Total Knee Replacement Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale New Haven Hospital Saint Raphael Campus, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Bupivacaine-Liposomal Bupivacaine

Drug

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 Acetate

Drug

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.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. Average Postoperative Knee Pain Score

    Time frame: Day 7

    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).

  2. Worst and best pain score

    Time frame: Day 1, Day 2 and Day 7

    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).

  3. Change in functional pain using Brief Pain Inventory (BPI)

    Time frame: baseline, 6 weeks and 3 months

    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.

  4. Change in neuropathic pain using PainDetect

    Time frame: baseline, 6 weeks and 3 months

    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.

  5. Persistent opioid use using Yale Postoperative Recovery Scale

    Time frame: Day 7, 6 weeks and 3 months

    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.

  6. Persistent opioid use using NarX

    Time frame: 6 weeks and 3 months

    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

  7. Change in Quality of Recovery 40 questionnaire

    Time frame: Day 1, 2 and 7

    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)

  8. Prosthetic joint range of motion

    Time frame: baseline, day 0, day 1 and day 2

    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

  9. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10

    Time frame: 6 weeks and 3 months

    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.

  10. Change in knee functional status using Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)

    Time frame: 6 weeks and 3 months

    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.

  11. Length of stay

    Time frame: from the start of the surgery to discharge from hospital, up to 48 hours

    The patient's post surgical length of stay in the hospital will be compared between treatment groups.

  12. Change in glucose

    Time frame: baseline, day 0, day 1 and day 2

    Compare the change in postoperative serum glucose from baseline only for participants that have an overnight hospital stay

  13. Change in white blood cell count (WBC)

    Time frame: baseline, day 0, day 1 and day 2

    Compare the change in postoperative WBC from baseline only for participants that have an overnight hospital stay

  14. Absolute value of Interleukin 1 beta (IL-1b)

    Time frame: day 1

    Absolute value IL-1b at postoperative day 1 only for participants that have an overnight hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Jinlei Li, MD PhD

CONTACT

[email protected]

475-434-4038

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Department of Anesthesiology Faculty Development Fund

Registry information

Official study title

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study

Acronym: Yale SEVEN

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 15, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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