Efficacy of EXPAREL vs. Bupivacaine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl).
Secondary objectives are to:
Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
* Compare the time to first opioid consumption following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Assess the safety of EXPAREL vs. 0.25% bupivacaine HCl * Evaluate subject satisfaction with pain management following a single-dose injection of EXPAREL vs. 0.25% bupivacaine hydrochloride (HCl) * Compare clinical performance from Preoperative status to 3- and 12- months postoperatively
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indicated to undergo unilateral total ankle arthroplasty
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
Body Mass Index (BMI) ≥18 and ≤40 kg/m2
Disqualifiers
Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period for pain, and which, in the Investigator's opinion, may confound the post-dosing assessments
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
Trial design
Design model
Parallel
Treatments tested in this trial
EXPAREL
DrugEXPAREL (bupivacaine liposome injectable suspension) is formulated as a sterile, non-pyrogenic, white to off-white, preservative-free homogenous suspension of bupivacaine encapsulated into multivesicular liposomes (pMVL drug delivery system). For this study, EXPAREL will be provided in 20 mL (266 mg) EXPAREL single-use, clear glass vials.
0.25% bupivacaine (HCl): 50 ml
DrugThe reference product is 50 mL (100 mg) 0.25% bupivacaine HCl administered via a combined sciatic (in the popliteal fossa) and saphenous nerve block (in the adductor canal)
0.25% bupivacaine (HCl): 30 ml
DrugEXPAREL admixed with 30 mL (75 mg) 0.25% bupivacaine HCl
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: AdmixExperimental treatment 2 interventions
Group B: ReferenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Magnitude of the analgesic effect
To measure this, the Area under the curve (AUC) of the Numeric Rating Scale (NRS) for both groups will be compared. The subjects will be asked to rate their worst or average pain on a scale of 0 (no pain) - 10 (worst possible pain) on numerous time points, starting upon arrival in the Post-Anesthesia Care Unit (PACU)
Time frame
Perioperative (Upon arrival in the PACU (±5 min), Postoperative (At PACU discharge (±5 min)), Every 6 hours from the end of surgery until health care facility discharge up to 96hSecondary outcomes
1
Total opioid consumption
Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
Time frame
Baseline (Hour 0), 96 hours post surgery2
Time to first opioid consumption
Compare the time to first opioid consumption in oral morphine equivalents (OMED) following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
Time frame
Baseline (Hour 0), 96 hours post surgery3
Patient safety
Safety of EXPAREL vs. 0.25% bupivacaine HCl will be assessed by the Incidence of treatment-emergent Adverse Events and Serious AEs from the start of the nerve block procedure through Post op day (POD) 14
Time frame
Baseline (Hour 0), Day 14 post op4
Subject satisfaction
Subject satisfaction with pain management following the intervention in both groups will be assessed using a Subject Satisfaction Questionnaire. This consists of a single question asking participants to rate their satisfaction with pain management outcomes on a scale from 0 to 10, where 0 indicates 'extremely dissatisfied' and 10 indicates 'extremely satisfied
Time frame
Within 96 hours post opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Pacira Pharmaceuticals, Inc
Collaborator
Source ClinicalTrials.gov