Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine-Liposomal Bupivacaine
DrugAdductor 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
DrugAdductor 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Bupivacaine-Liposomal Bupivacaine (B-LB)Active comparator 1 intervention
Group B: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Day 1 and Day 22
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
Time frame
From anesthesia end time to discharge time, up to 48 hoursSecondary outcomes
1
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).
Time frame
Day 72
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).
Time frame
Day 1, Day 2 and Day 73
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.
Time frame
baseline, 6 weeks and 3 months4
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.
Time frame
baseline, 6 weeks and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Department of Anesthesiology Faculty Development Fund
Collaborator
Source ClinicalTrials.gov