Clinical trial NCT05279092: Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Official title: Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Total Knee Replacement
Knee Arthroplasty
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Department of Anesthesiology Faculty Development Fund
First posted: 2022-03-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Knee Pain Score
timeFrame: Day 1 and Day 2
measure: Postoperative opioid consumption
timeFrame: From anesthesia end time to discharge time, up to 48 hours
Secondary outcomes:
measure: Average Postoperative Knee Pain Score
timeFrame: Day 7
measure: Worst and best pain score
timeFrame: Day 1, Day 2 and Day 7
measure: Change in functional pain using Brief Pain Inventory (BPI)
timeFrame: baseline, 6 weeks and 3 months
measure: Change in neuropathic pain using PainDetect
timeFrame: baseline, 6 weeks and 3 months
measure: Persistent opioid use using Yale Postoperative Recovery Scale
timeFrame: Day 7, 6 weeks and 3 months
measure: Persistent opioid use using NarX
timeFrame: 6 weeks and 3 months
measure: Change in Quality of Recovery 40 questionnaire
timeFrame: Day 1, 2 and 7
measure: Prosthetic joint range of motion
timeFrame: baseline, day 0, day 1 and day 2
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
timeFrame: 6 weeks and 3 months
measure: Change in knee functional status using Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
timeFrame: 6 weeks and 3 months
measure: Length of stay
timeFrame: from the start of the surgery to discharge from hospital, up to 48 hours
measure: Change in glucose
timeFrame: baseline, day 0, day 1 and day 2
measure: Change in white blood cell count (WBC)
timeFrame: baseline, day 0, day 1 and day 2
measure: Absolute value of Interleukin 1 beta (IL-1b)
timeFrame: day 1
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital Saint Raphael Campus
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital York Street Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Jinlei Li, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: